Alere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
Alere San Diego is recalling multiple hCG urine pregnancy test models because they may detect low hCG levels, resulting in false positive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without reported illness.
Plain-English summary
Alere San Diego, Inc. is recalling several models of hCG urine pregnancy tests, including Fisher Scientific Sure-Vue, Henry Schein One Step, Alere hCG Cassette, Cardinal Health hCG Cassette, Medline HCG Pregnancy Test, and Pro Advantage By NDC Urine Pregnancy Cassette. The recall affects 18,139,960 units distributed worldwide, including nationwide in the United States and in various international locations.
The recall is issued because the hCG rapid tests may detect low levels of hCG below the stated assay sensitivity. This defect may result in false positive results. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers should stop using the affected products. The source text does not provide specific instructions for disposal or replacement, but users should refer to the manufacturer or their healthcare provider for guidance on next steps.
The recalled product
- Product
- Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073; Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217; Cardinal Health hCG Cassette Rapid test…
- Manufacturer
- Alere San Diego, Inc.
- Category
- Medical Device — Pregnancy Test
- Hazard
- Affected units
- 18,139,960
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 (12)
- 2018-01-15
- 9004074/10304040024116/1155875704
- 2014-06-09
- 9004073/10304040024109/1155875704
- 92217/10815845020109/1156015703
- 07/16
- B1077-22/20885380020251/1155904704
- 9/2014
- MPH12025HCG/10888277191877/1156093302
- 2015-03-20
- P080063/M220P0800633/40001853
- 2023-03-30
Distribution
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