Z-3271-2026 Class II Ongoing
FDA device recall Z-3271-2026 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: 50,265,835.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 20, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,265,835
Product Description
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/Urine¿hCG-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;
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: 5001/ 20612479202744/1155958203, 12/15; 92210/10815845020130/1156015803, 07/16; 23900530/00613647000571/1155810105, 2018-01-15; 23900531/00613647000533/1155810105, 2018-01-15; 5002/20612479202768/1155958305, 12/15; 92215/10815845020123/1156015903, 07/16; B-1077-23/20885380020268/1155904805, 9/2014; MPH22025HCG/10884389191880/1156093402, 04-01-2015
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3271-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026