Alere hCG Urine Test Strips Recalled for False Positive Risk
Alere San Diego is recalling multiple hCG urine test strips because they may detect low hCG levels, resulting in false positive results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a diagnostic error (false positive) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
Alere San Diego, Inc. is recalling approximately 13,256,075 units of hCG urine test strips. The affected products include the Fisher Scientific Sure-Vue Urine hCG Strip, McKesson CONSULT hCG Urine Test Dipstick, Henry Schein One Step+ hCG Urine Strip Test, Alere hCG Dipstick, Cardinal Health hCG Dipstick Rapid Test, Medline hCG Pregnancy Test Strip, and Pro Advantage by NDC Urine Pregnancy Test Strip. The recall covers all lots within the expiration date.
The recall was initiated because the hCG rapid tests may detect low levels of hCG below the stated assay sensitivity. This potential issue may result in false positive results. The products were distributed worldwide, including nationwide in the United States and in various international locations.
Consumers and healthcare providers should stop using the affected test strips. Users should consult the manufacturer or their healthcare provider for further instructions regarding the recall and potential re-testing.
The recalled product
- Product
- 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…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 13,256,075
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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
Distribution
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