Fisher Scientific Sure-Vue Urine hCG Strip recall (Alere San Diego, Inc.)
Medical deviceClass IIOngoing
Summary: Alere San Diego, Inc. is recalling Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-101/9004072; Alere hCG Dipstick (25mIU/mL) in Urine, Model/ Part: FHC-101/92211;. Reason: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
What is being recalled
Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-101/9004072; Alere hCG Dipstick (25mIU/mL) in Urine, Model/ Part: FHC-101/92211; Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Model/ Part: FHC-101/B-1077-21; Medline hCG Pregnancy Test Strip, Model/ Part: FHC-101/MPH11025HCG; Pro Advantage by NDC Urine Pregnancy Test Strip, Model/ Part: FHC-101/P080023;
Why
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden. (states named: Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming)
How to tell if yours is affected
All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900527/00613647000588/1155811305, 2018-01-15; 5000/20612479202751/40008059, V05; 9004072/10304040024093/1155800504, 2014-06-09; 92211/10815845020093/40008089, 05/25; B-1077-21/20885380020244/40008054, 04/2025; MPH11025HCG/10884389191873/40006717, 6/2025; P080023/M220P0800233/40008087, 2025-05-09
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3273-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 20, 2026 |
| Reported | October 7, 2026 |
| Company | Alere San Diego, Inc. |
| Company location | San Diego, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 13,256,075 |
More recalls from Alere San Diego, Inc. · all medical device recalls · recalls from August 2026