Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse… — Class II medical device recall Z-1540-2021
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 Emergency Use Application (EUA) application withdrawn as false negative results reported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-1540-2021 |
|---|---|
| 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) |
| Model numbers | 410700IVD |
Product
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Emergency Use Application (EUA) application withdrawn as false negative results reported
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-1540-2021. 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.