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U.S. Department of Health and Human Services

Class 2 Device Recall Meridan

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 Class 2 Device Recall Meridansee related information
Date Initiated by FirmDecember 15, 2022
Date PostedJanuary 20, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1008-2023
Recall Event ID 91356
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
ProductRevogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Code Information UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244-3023
For Additional Information ContactRyan Spradling
800-343-3858
Manufacturer 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
FDA Determined
Cause 2		Process control
ActionMeridian 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.
Quantity in Commerce92 kits
DistributionUS Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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