Recall Z-1541-2021— Meridian Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2021-04-08, terminated 2021-10-26. FDA's recall record names no specific 510(k) clearance for this event. 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 Reason: Emergency Use Application (EUA) application withdrawn as false negative results reported.
- Recalling firm
- Meridian Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-08
- Terminated
- 2021-10-26
- Firm location
- Cincinnati, OH, United States
Product description
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 for recall
Emergency Use Application (EUA) application withdrawn as false negative results reported
Data sourced from openFDA. This site is unofficial and independent of the FDA.