FDA-Device2026-10-07Class IIPROCESSING DEFECT
Multiple brands of hCG urine pregnancy test strips recalled for false positive risk
What this means
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.
- Do not use affected test strips if you have one of the recalled models listed on the FDA notice.
- If you have already taken one of these tests and received a positive result, contact your healthcare provider to confirm the result with a blood test or clinical evaluation.
- Return unused strips to the distributor or manufacturer if possible, or dispose of them according to your local guidelines.
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
13,256,075
Manufactured in
9942 mesa rim rd, San Diego, CA, United States
Products
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/ Part: FHC-101/92211; Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Model/ Part: FHC-101/B-1077-21; Medline hCG Pregnancy Test Strip, Model/ Part: FHC-101/MPH11025HCG; Pro Advantage by NDC Urine Pregnancy Test Strip, Model/ Part: FHC-101/P080023;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3273-2026More Alere recalls
- 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;
- FDA-Device2026-10-07Multiple brands of hCG pregnancy tests recalled for false positive risk
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.