Device recall
Z-2981-2020: Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-2981-2020 |
|---|---|
| Recall event | 86319 |
| Product | Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190 |
| Product code | JZO |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2021 |
| 510(k) numbers | K051890 |
| 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