Device recall
Z-1019-2026: Revogene C. difficile, in vitro diagnostic assay intended for use with the…
FDA device recall · Class II · Meridian Bioscience Inc
Key facts
| Recall number (Z-number) | Z-1019-2026 |
|---|---|
| Recall event | 98038 |
| Product | Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 |
| Product code | OZN |
| Recalling firm | Meridian Bioscience Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172569 |
| FEI number | 1524213 |
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