Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs… — Class II medical device recall Z-1541-2021
Terminated recall by Meridian Bioscience Inc, reported 2021-05-19, distributed nationwide. Emergency Use Application (EUA) application withdrawn as false negative results reported
| Recall number | Z-1541-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meridian Bioscience Inc, Cincinnati, OH, United States |
| Recall initiated | 2021-04-08 |
| Classified | 2021-05-07 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2021-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 124 revogene |
| Model numbers | 610240IVD |
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 for recall
Emergency Use Application (EUA) application withdrawn as false negative results reported
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1541-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.