Device recall
Z-3272-2026: Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529…
FDA device recall · Class II · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-3272-2026 |
|---|---|
| Recall event | 99409 |
| 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… |
| Product code | JHI |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K993065 |
| FEI number | 1000125596 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database