FDA Device recall Z-3271-2026
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001 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-3271-2026 |
| 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
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
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: 5001/ 20612479202744/1155958203, 12/15; 92…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 |
|---|
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 - Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528
FDA Device · Class II · 2026-10-07 · Alere San Diego - Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3271-2026%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.