Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Urine hCG

Recalling company

Alere San Diego, Inc.

Product

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 Advantage By NDC Urine Pregnancy Cassette Device, Model/ Part: FHC-102/P080063;

Reason

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 20, 2026

Reported

Oct 7, 2026

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, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.

Status

Ongoing

Quantity

18,139,960

Lot / codes

All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900526/00613647000526/1155811105, 2018-01-15; 9004074/10304040024116/1155875704, 2014-06-09; 9004073/10304040024109/1155875704, 2014-06-09; 92217/10815845020109/1156015703, 07/16; B1077-22/20885380020251/1155904704, 9/2014; MPH12025HCG/10888277191877/1156093302, 2015-03-20; P080063/M220P0800633/40001853, 2023-03-30

Company location

San Diego, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-3274-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3274-2026 in the FDA Enforcement Report. Also see FDA recall press releases.