Z-1541-2021 Class II Terminated
FDA device recall Z-1541-2021 was initiated by Meridian Bioscience Inc on April 8, 2021 and is designated Class II. Reason for recall: Emergency Use Application (EUA) application withdrawn as false negative results reported The recall status is terminated (terminated October 26, 2021). Affected quantity: 124 Revogene RNA Software Upgrade Kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- April 8, 2021
- Termination Date
- October 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124 Revogene RNA Software Upgrade Kits
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Emergency Use Application (EUA) application withdrawn as false negative results reported
Distribution Pattern
Nationwide
Code Information
All lot numbers