Recalls in Arkansas (page 35)
3931 recalls.
- Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - 1) UNIVERSAL KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: ... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: ... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. recall (Hologic, Inc)
Medical deviceClass IIReported February 18, 2026 · Presence of particulates in affected devices that can be deposited into breast tissue during use. - Intubation Tray recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the... - Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the... - Watkins Manufacturing Recalls Hydromassage Rotary Jets in Highlife Collection Spas Due to Entanglement and Drowning Hazards
Consumer productReported February 13, 2026 · The hydromassage rotary jets can create a suction force that allows the user's hair to be entangled, submerging their head underwater, posing entanglement and... - Beloems Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails
Consumer productReported February 13, 2026 · The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed... - CheerKid Baby Bath Seats Recalled Due to Risk of Serious Injury or Death to Children from Drowning; Violates Mandatory Standard for Infant Bath Seats; Sold on Amazon by Babibaby and Woot
Consumer productReported February 13, 2026 · The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posing a risk of serious... - Surveying Accessories Cheaper Recalls Board Games Due to Risk of Serious Injury or Death from Magnet Ingestion; Violates Mandatory Standard for Toys
Consumer productReported February 13, 2026 · The recalled board games violate the mandatory standard for toys because the magnetic game pieces contain loose high-powered magnets, posing an ingestion... - Fortemotus Direct Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails
Consumer productReported February 13, 2026 · The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed... - SOOWERY 6-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units
Consumer productReported February 12, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - LShome Photoelectric Smoke Detector Fire Alarms Recalled Due Failure to Warn During Fire Posing Serious Injury or Death Hazard; Sold Exclusively on Amazon.com by TIANJINSHIHAOWEIXINSHENGJIDIANANZHUANGGONGCHENG
Consumer productReported February 12, 2026 · If the sensing threshold of security warnings is set too high, the alarm might not sound in a timely manner, posing a fire hazard. - DriBiz Recalls Ammo Tabs Desiccant Tiles Due to Injury Hazard
Consumer productReported February 12, 2026 · The Ammo Tab can fail to protect the firearms and ammunition from humidity, allowing excess moisture to cause corrosion or rust that can increase the risk of... - Airova Recalls Aroeve Air Purifiers Due to Fire and Burn Hazards
Consumer productReported February 12, 2026 · The air purifiers can overheat and ignite, posing fire and burn hazards to consumers. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V ... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Vortex Surgical Lindsell Sutured IOL Marker recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical 25GA Backflush recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical TID Pharos Illuminated Depressor recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · XXX - Rumex Disposable Diamond Dusted ILM Elevator recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical I2 Injection Kit recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Tecfen Retractable Membrane Polisher recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical 25GA I.D.D. Internal Delivery Device recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - 25GA Subretinal Injection Cannula VS0220.25 recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 ... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Swiss Chocolate Cake Mix recall (B.C. Williams Bakery Service, Inc)
FoodClass IReported February 11, 2026 · Undeclared Milk Allergen - Bread and Roll Mix recall (B.C. Williams Bakery Service, Inc)
FoodClass IReported February 11, 2026 · Undeclared Milk Allergen - Spice Cake Mix recall (B.C. Williams Bakery Service, Inc)
FoodClass IReported February 11, 2026 · Undeclared Milk Allergen - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Sea Moss Gel Superfood recall (Diva Fam Inc)
FoodClass IIReported February 11, 2026 · potential Clostridium botulinum contamination - Lost and Found Energy recall (Fazt & Loud LLC)
FoodClass IIIReported February 11, 2026 · Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of... - Diclofenac Sodium recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIReported February 11, 2026 · Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. - Trazodone Hydrochloride recall (Granules Pharmaceuticals Inc.)
DrugClass IIReported February 11, 2026 · Presence of Foreign Tablets/Capsules - Bisoprolol Fumarate and Hydrochlorothiazide tablets recall (Unichem Pharmaceuticals USA Inc.)
DrugClass IIReported February 11, 2026 · cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. - Brand Name: Molift Product Name: Molift 4-point sling bars recall (ETAC A/S)
Medical deviceClass IIReported February 11, 2026 · A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this... - Brand Name: Molift Product Name: Molift 2-point sling bars recall (ETAC A/S)
Medical deviceClass IIReported February 11, 2026 · A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this... - Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: recall (ETAC A/S)
Medical deviceClass IIReported February 11, 2026 · A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this... - Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: recall (ETAC A/S)
Medical deviceClass IIReported February 11, 2026 · A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this... - Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 ... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number:... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low... - Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 ... recall (Fujirebio Diagnostics, Inc.)
Medical deviceClass IIReported February 11, 2026 · Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low...