Device recall
Z-0530-2014: remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml…
FDA device recall · Class II · Remel Inc
Key facts
| Recall number (Z-number) | Z-0530-2014 |
|---|---|
| Recall event | 65477 |
| Product | remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms. |
| Product code | JXB |
| Recalling firm | Remel Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 12, 2014 |
| 510(k) numbers | K943621 |
| FEI number | 1924669 |
At a glance
- 1–9 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