Recall Z-3274-2026 · JHI Visual, Pregnancy Hcg, Prescription Use

Alere San Diego, Inc.

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 CLIA Waived, Model/ Part: FHC-102/B1077-22; Medline HCG Pregnancy Test Cassette, Model/ Part: FHC-102/MPH12025HCG; Pro Advant

Date	Sep 25, 2026 (initiated Aug 20, 2026)
Status	Open, Classified
Reason	hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Root cause	Device Design
Action	On 8/20/2026, correction notices started being emailed to customers and distributors informing them to take the following actions: 1) In situations where an unexpected test result is obtained, consider all limitations, including peri-menopause that may result in low levels of hCG. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated, and an alternate confirmatory test that supports a timely clinical decision has been considered. 2) If you have forwarded affected products to other laboratories within your distribution
Quantity	18,139,960
Distribution	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, Irel
FDA record	Open on fda.gov

510(k) clearances named in this recall

K993317

ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
ACON Laboratories, Inc., Dec 1, 1999