Meridian Bioscience Inc Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Brand
Meridian Bioscience Inc
Lot Codes / Batch Numbers
UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027
Products Sold
UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027
Meridian Bioscience Inc is recalling Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SAR due to Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized sp. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Meridian Bioscience issued Urgent Medical Device Recall on 12/15/22 via email. The letter states reason for recall, health risk and action to take: REQUIRED ACTIONS: " Inspect the rotor, ring, and chamber walls of the Revogene instrument for signs of leakage (e.g., dried spots). Contact Meridian Bioscience Technical Service if any signs of leakage were detected. " If leakage is suspected, clean the Revogene, MOCK PIEs, and surrounding workspace using the instructions in the Revogene operator's manual. " Review current inventory and segregate any remaining stock. " Discontinue use of any remaining stock. " Contact Meridian Technical Support 800.343.3858 to obtain a FedEx label to return any remaining inventory to Meridian Bioscience Inc. for credit. " Complete and return the Customer Notification Form. This will indicate receipt of this field correction notice. Complete this form even if you have no remaining inventory. Questions, please call Meridian Bioscience Technical Services at 1-800-343-3858, or email at MBI_TechService@meridianbioscience.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026