Alere recalls
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Alere and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-10-07FDA-DeviceClass IIFisher 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 CLIA Waived, Model/ Part: FHC-102/B1077-22; Medline HCG Pregnancy Test Cassette, Model/ Part: FHC-102/MPH12025HCG; Pro Advantage By NDC Urine Pregnancy Cassette Device, Model/ Part: FHC-102/P080063;
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- 2026-10-07FDA-DeviceClass IIhCG urine pregnancy test strips recalled for false positive results
Alere San Diego manufactured hCG urine test strips sold under multiple brand names (Fisher Scientific, McKesson, Henry Schein, Cardinal Health, Medline, and others). These tests may incorrectly show a positive result when hCG levels are below the test's stated sensitivity threshold, leading to a false positive pregnancy indication.
- 2026-10-07FDA-DeviceClass IIhCG pregnancy tests recalled for false positive results
Several brands of rapid hCG (pregnancy hormone) tests may incorrectly detect low levels of hCG below their stated sensitivity threshold, potentially showing a positive result when hCG is not actually present. This affects over 5 million test kits distributed worldwide, including in the U.S. and several other countries.
- 2026-10-07FDA-DeviceClass IIMultiple brands hCG pregnancy tests recalled for false positives
Certain hCG rapid pregnancy tests may incorrectly detect low levels of hCG below their stated sensitivity range, potentially leading to false positive results. The affected tests were distributed nationwide and internationally and include multiple brand names sold under McKesson, Alere, Fisher Scientific, Cardinal Health, and Medline labels. No injuries have been reported.
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