Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the… — Class II medical device recall Z-1008-2023
Ongoing recall by Meridian Bioscience Inc, reported 2023-02-01, distributed nationwide. Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory pe
| Recall number | Z-1008-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meridian Bioscience Inc, Cincinnati, OH, United States |
| Recall initiated | 2022-12-15 |
| Classified | 2023-01-20 |
| Reported by FDA | 2023-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 92 kits |
| Reason classes | packaging |
| Lot numbers | 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027 |
| Model numbers | 410700 |
Product
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Reason for recall
Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
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-1008-2023. 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.