Device recall
Z-1541-2021: Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog…
FDA device recall · Class II · Meridian Bioscience Inc
Key facts
| Recall number (Z-number) | Z-1541-2021 |
|---|---|
| Recall event | 87556 |
| Product | Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file |
| 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