Device 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
Z-1541-2021
Product summary
- Event
- Event 87556
- Status
- Terminated
- Classification
- Class II
- Quantity
- 124 Revogene RNA Software Upgrade Kits
- Official record key
device-enforcement:Z-1541-2021
Official wording
Reason: Emergency Use Application (EUA) application withdrawn as false negative results reported
Code information: All lot numbers
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Emergency Use Application (EUA) application withdrawn as false negative results reported