Device recall
Z-2920-2020: Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number…
FDA device recall · Class II · Remel Europe Ltd.
Key facts
| Recall number (Z-number) | Z-2920-2020 |
|---|---|
| Recall event | 86109 |
| Product | Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological… |
| Product code | GOY |
| Recalling firm | Remel Europe Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2022 |
| FEI number | 3003750284 |
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