Alere San Diego, Inc. — 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/UrinehCG-STA

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider

FDA — device enforcement reference

Source observed

8/20/2026, 12:00:00 AM UTC

Source updated

9/25/2026, 12:00:00 AM UTC

Location

San Diego, CA, US

hazard

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

notice

Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.

product

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/UrinehCG-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;

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.

event number

99409

manufacturer

Alere San Diego, Inc.

recall number

Z-3271-2026

source status

Open, Classified

freshness minutes

180

Source use policy · openFDA reference data; not a real-time public alert service

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