Z-1540-2021 Class II Terminated
FDA device recall Z-1540-2021 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 Reason for recall: Emergency Use Application (EUA) application withdrawn as false negative results reported The recall status is terminated (terminated October 26, 2021).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: 376 kits of the Revogene SARS-CoV-2 assay.
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
- 376 kits of the Revogene SARS-CoV-2 assay
Product Description
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19
Reason for Recall
Emergency Use Application (EUA) application withdrawn as false negative results reported
Distribution Pattern
Nationwide
Code Information
All lot numbers