Z-1008-2023 Class II Ongoing
FDA device recall Z-1008-2023 was initiated by Meridian Bioscience Inc on December 15, 2022 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 92 kits.
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2023
- Initiation Date
- December 15, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92 kits
Product Description
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
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.
Code Information
UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027