FDA-Device2026-10-07Class IIPROCESSING DEFECT
Alere, McKesson, Fisher Scientific, Cardinal Health, and Medline hCG rapid tests recalled for false positive results
What this means
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.
- If you have one of the affected hCG test kits, do not use it and contact your healthcare provider if you have concerns about a pregnancy test result.
- Contact the manufacturer or distributor listed on your test kit packaging for instructions on obtaining a replacement or refund.
- If you received a positive result on one of these tests, confirm the result with a clinical blood test ordered by your doctor.
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
Adults
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
50,265,835
Manufactured in
9942 mesa rim rd, San Diego, CA, United States
Products
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FHC-A202/23900531, FHC-A202/23900530; McKesson CONSULT Diagnostics hCG Urine Cassette, Model/ Part: FHC-A202/5002; Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum, Model/ Part: FHC-A202/92215; Cardinal Health hCG Combo Rapid Test Serum or Urine, Model/ Part: FHC-A202/B-1077-23; Medline hCG Combo Pregnancy Test Cassette, Model/ Part: FHC-A202/MPH22025HCG;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3271-2026More Alere recalls
- FDA-Device2026-10-07Multiple brands of hCG urine pregnancy test strips recalled for false positive risk
- 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;
- FDA-Device2026-10-07Multiple brands of hCG pregnancy tests recalled for false positive risk
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