Class II — Meridian Bioscience Inc
| Recalling firm | MERIDIAN BIOSCIENCE, INC. |
|---|---|
| Registered facility | MERIDIAN BIOSCIENCE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Product | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700 |
| Quantity | 92 kits |
| Distribution | US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX. |
| Initiated | 2022-12-15 |
| Classified | 2023-01-20 |
| Recall number | Z-1008-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Meridian Bioscience Inc (Z-1008-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91356/
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