FDA-Device2026-10-07Class IIPROCESSING DEFECT
Multiple brands of hCG pregnancy tests recalled for false positive risk
What this means
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.
- If you have one of these tests, stop using it and do not rely on the result
- Contact your healthcare provider or take an alternative pregnancy test if you need accurate results
- Return the test to the manufacturer or retailer if you wish to do so
The agency's original wording
Hazard
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.
Affected count
5,331,585
Manufactured in
9942 mesa rim rd, San Diego, CA, United States
Products
Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075; Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225; Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3272-2026More Alere recalls
- FDA-Device2026-10-07Multiple brands of hCG urine pregnancy test strips recalled for false positive risk
- FDA-Device2026-10-07Alere, McKesson, Fisher Scientific, Cardinal Health, and Medline hCG rapid tests recalled for false positive results
- FDA-Device2026-10-07Fisher 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;
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