Instrumentation Laboratory recalls
32 recalls.
- HemoslL AcuStar HIT-lgG recall (Instrumentation Laboratory)
Medical deviceClass IReported October 21, 2026 · Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. - HemoslL AcuStar HIT-lgG recall (Instrumentation Laboratory)
Medical deviceClass IReported October 21, 2026 · Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. - GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 ... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 12, 2026 · The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The... - GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 ... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 12, 2026 · The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing... - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 5, 2026 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 5, 2026 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 5, 2026 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 5, 2026 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 5, 2026 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 5, 2026 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - GEM Premier 5000 PAK recall (Instrumentation Laboratory)
Medical deviceClass IIReported March 18, 2026 · Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution... - The product is used for the evaluation of the intrinsic coagulation pathway recall (Instrumentation Laboratory)
Medical deviceClass IIReported January 21, 2026 · Potential for microbial contamination. - HemosIL SynthAFax. Partial Thromboplastin Time Tests. recall (Instrumentation Laboratory)
Medical deviceClass IIIReported December 24, 2025 · Recalled lots were manufactured with double the amount of preservative concentration.