Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON…
Alere San Diego, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alere San Diego, Inc. · 9942 mesa rim rd · San Diego, CA · 92121-2997
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
FHC-202/23900529 | Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ , FHC-202/23900528 |
FHC-202/43025 | Beckman Coulter Inc's ICON 25 hCG, Model/ |
FHC-202/9004075 | Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ |
FHC-202/92225 | Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ |
FHC-202/P080021 | Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ |
- Lot codes and dates
6 of 6 products · 11 lot codes
Recalled lot codes, grouped by product number Parts UDI-DI Labeling Versions Through 239005290061364700054011558109062018-01-15
239005280061364700056411558109062018-01-15
4302515099590776886May 2015
90040751030404002412311558758042014-06-09
9222510815845020116115601560307/16
P080021M220P0800213400018562023-03-30
- Amount recalled
- 5,331,585
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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