Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part:…
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?
7 of 7 products
| Model / number | Product as published |
|---|---|
FHC-A102/5001 | McKesson CONSULT hCG Urine Cassette, Model/ |
FHC-A102/92210 | Alere hCG Cassette (20 mIU/mL) in Urine, Model/ |
FHC-A202/23900531 | Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ , FHC-A202/23900530 |
FHC-A202/5002 | McKesson CONSULT Diagnostics hCG Urine Cassette, Model/ |
FHC-A202/92215 | Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum, Model/ |
FHC-A202/B-1077-23 | Cardinal Health hCG Combo Rapid Test Serum or Urine, Model/ |
FHC-A202/MPH22025HCG | Medline hCG Combo Pregnancy Test Cassette, Model/ |
- Lot codes and dates
8 of 8 products · 16 lot codes
Recalled lot codes, grouped by product number Parts UDI-DI Labeling Versions Through 500120612479202744115595820312/15
9221010815845020130115601580307/16
239005300061364700057111558101052018-01-15
239005310061364700053311558101052018-01-15
500220612479202768115595830512/15
9221510815845020123115601590307/16
B-1077-232088538002026811559048059/2014
MPH22025HCG10884389191880115609340204-01-2015
- Amount recalled
- 50,265,835
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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