Z-3272-2026 Class II Ongoing
FDA device recall Z-3272-2026 was initiated by Alere San Diego, Inc. on Aug 20, 2026 and is designated Class II. Reason for recall: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. The recall status is ongoing. Affected quantity: 5,331,585.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 20, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,331,585
Product Description
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.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3272-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026