Device recall
Z-0727-2025: Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the…
FDA device recall · Class II · Beckman Coulter, Inc.
Key facts
| Recall number (Z-number) | Z-0727-2025 |
|---|---|
| Recall event | 95816 |
| Product | Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma. |
| Product code | MMI |
| Recalling firm | Beckman Coulter, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K121214, K172783, K222881, K230648 |
| FEI number | 2122870 |
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