Alere San Diego, Inc.: Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Par

Company / brand

Alere San Diego, Inc.

Product

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;

Reason / hazard

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

Classification

Class II

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2026-08-20

Code info

All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900527/00613647000588/1155811305, 2018-01-15; 5000/20612479202751/40008059, V05; 9004072/10304040024093/1155800504, 2014-06-09; 92211/10815845020093/40008089, 05/25; B-1077-21/20885380020244/40008054, 04/2025; MPH11025HCG/10884389191873/40006717, 6/2025; P080023/M220P0800233/40008087, 2025-05-09

Product quantity

13,256,075

Voluntary mandated

Voluntary: Firm initiated

City

San Diego

State

CA

Country

United States

Event id

99409

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