FDAFDA recall Z-3272-2026 · Oct 7, 2026

Alere San Diego, Inc.: Fisher Scientific Sure-Vue Serum/Urine hCG recall

Recall found

Product

Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075; Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225; Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021

Reason for recall

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

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900529/00613647000540/1155810906, 2018-01-15; 23900528/00613647000564/1155810906, 2018-01-15; 43025/15099590776886/May 2015; 9004075/10304040024123/1155875804, 2014-06-09; 92225/10815845020116/1156015603, 07/16; P080021/M220P0800213/40001856, 2023-03-30
Quantity: 5,331,585
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.
Recalling firm: Alere San Diego, Inc., San Diego, CA
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-08-20

Source: openFDA enforcement record Z-3272-2026 · search recall number Z-3272-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.