Device recall
Z-0234-2025: Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a)…
FDA device recall · Class II · Abbott Molecular, Inc.
Key facts
| Recall number (Z-number) | Z-0234-2025 |
|---|---|
| Recall event | 95442 |
| Product | Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091; |
| Product code | QEP |
| Recalling firm | Abbott Molecular, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K222379 |
| FEI number | 3005248192 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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