Device recall
Z-0525-2022: API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-0525-2022 |
|---|---|
| Recall event | 89329 |
| Product | API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually… |
| Product code | JXB |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2023 |
| FEI number | 1950204 |
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