Drug recall
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to…
FDA recall event 87556 · Class II · Meridian Bioscience Inc
Key facts
| Event ID | 87556 |
|---|---|
| Recall numbers | Z-1540-2021, Z-1541-2021 |
| Recalling firm | Meridian Bioscience Inc |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Emergency Use Application (EUA) application withdrawn as false negative results reported |
| Initiation date | Apr 8, 2021 |
| Report date | May 19, 2021 |
| Termination date | Oct 26, 2021 |
| City | Cincinnati |
| State | OH |
| Country | United States |
| FEI number | 1524213 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: