FDA Device recall Z-1541-2021
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Softwar…
- FDA Device
- Class II
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Softwar… by Meridian Bioscience, citing emergency Use Application (EUA) application withdrawn as false negative results reported.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1541-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-08 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Meridian Bioscience |
| Distribution | US |
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
Reason
Emergency Use Application (EUA) application withdrawn as false negative results reported
Identifiers
| code_info | All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1541-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.