Meridian Bioscience Inc Recall 91356
Description: Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Meridian Bioscience Inc Recall 91356 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1008-2023 |
| Event ID | 91356 |
| Event Description | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX. |
| Quantity | 92 kits |
| Recall 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 |
| Device Classification | 20230201 |
| Device Code Info | UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027 |
| Center Classification Date | 20230120 |
| Recall Initiation Date | 20221215 |
| Recalling Firm | Meridian Bioscience Inc |
| Initial Notification | |
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