Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from...
FDA Recall #Z-1008-2023 — Class II — December 15, 2022
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
Recalling Firm
Meridian Bioscience Inc — Cincinnati, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
92 kits
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated