Device recall
Z-1008-2023: Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative…
FDA device recall · Class II · Meridian Bioscience Inc
Key facts
| Recall number (Z-number) | Z-1008-2023 |
|---|---|
| Recall event | 91356 |
| Product | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700 |
| Product code | QJR |
| Recalling firm | Meridian Bioscience Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1524213 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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