Device recall
Z-1540-2021: Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse…
FDA device recall · Class II · Meridian Bioscience Inc
Key facts
| Recall number (Z-number) | Z-1540-2021 |
|---|---|
| Recall event | 87556 |
| Product | Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19 |
| Product code | QJR |
| Recalling firm | Meridian Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2021 |
| 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