FDA Device recall Z-3272-2026
Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528 by Alere San Diego, citing hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3272-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-20 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Alere San Diego |
| Distribution | US |
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
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Identifiers
| code_info | All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900529/00613647000540/1155810906, 2018-0…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Alere San Diego
- Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527
FDA Device · Class II · 2026-10-07 · Alere San Diego - McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001
FDA Device · Class II · 2026-10-07 · Alere San Diego - Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526
FDA Device · Class II · 2026-10-07 · Alere San Diego - Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3272-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.