Meridian Bioscience Inc Recall 87556
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
Meridian Bioscience Inc Recall 87556 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1540-2021 |
| Event ID | 87556 |
| Event 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 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 376 kits of the Revogene SARS-CoV-2 assay |
| Recall Reason | Emergency Use Application (EUA) application withdrawn as false negative results reported |
| Device Classification | 20210519 |
| Device Code Info | All lot numbers |
| Center Classification Date | 20210507 |
| Recall Initiation Date | 20210408 |
| Recalling Firm | Meridian Bioscience Inc |
| Initial Notification | Letter |
| Similar To |