Device recall
Z-1387-2012: Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of…
FDA device recall · Class I · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1387-2012 |
|---|---|
| Recall event | 61249 |
| Product | Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction. |
| Product code | MMI |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 6, 2013 |
| 510(k) numbers | K082699 |
| FEI number | 1823260 |
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