Device recall
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
- Recall number
- Z-3272-2026
- Event id
- 99409
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Alere San Diego, Inc.
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 20, 2026
- Center classification date
- Sep 25, 2026
- Product code
- JHI
- Device type
- Visual, Pregnancy Hcg, Prescription Use
- Reason
- hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- Root cause
- Device Design
- Quantity
- 5,331,585
- Code info
- 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
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K993065
- Location
- San Diego, CA, United States