Z-3274-2026 Class II Ongoing
FDA device recall Z-3274-2026 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: 18,139,960.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 20, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,139,960
Product Description
Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073; Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217; Cardinal Health hCG Cassette Rapid test CLIA Waived, Model/ Part: FHC-102/B1077-22; Medline HCG Pregnancy Test Cassette, Model/ Part: FHC-102/MPH12025HCG; Pro Advantage By NDC Urine Pregnancy Cassette Device, Model/ Part: FHC-102/P080063;
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: 23900526/00613647000526/1155811105, 2018-01-15; 9004074/10304040024116/1155875704, 2014-06-09; 9004073/10304040024109/1155875704, 2014-06-09; 92217/10815845020109/1156015703, 07/16; B1077-22/20885380020251/1155904704, 9/2014; MPH12025HCG/10888277191877/1156093302, 2015-03-20; P080063/M220P0800633/40001853, 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-3274-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026