Device recall
Z-0290-2018: Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01…
FDA device recall · Class II · Remel Inc
Key facts
| Recall number (Z-number) | Z-0290-2018 |
|---|---|
| Recall event | 78728 |
| Product | Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes. |
| Product code | GNB |
| Recalling firm | Remel Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2020 |
| FEI number | 1924669 |
At a glance
- None 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