Device recall
Z-1790-2014: Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1790-2014 |
|---|---|
| Recall event | 68294 |
| Product | Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes… |
| Product code | JJE |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2015 |
| 510(k) numbers | K961481 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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