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U.S. Department of Health and Human Services

Class 2 Device Recall Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs

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  Class 2 Device Recall Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs see related information
Date Initiated by Firm April 08, 2021
Create Date May 07, 2021
Recall Status1 Terminated 3 on October 26, 2021
Recall Number Z-1541-2021
Recall Event ID 87556
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product Revogene RNA Software Upgrade Kit
Revogene RNA Software Upgrade USBs
Catalog Number: 610240

IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file
Code Information All lot numbers
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244-3023
For Additional Information Contact Chris Ross
800-343-3858
Manufacturer Reason
for Recall		 Emergency Use Application (EUA) application withdrawn as false negative results reported
FDA Determined
Cause 2		 Under Investigation by firm
Action Meridan issued Urgent Medical Device Recall on 4/08/21 to the user level via phone and electronic mailing . Letter states reason for recall, health risk and action to take: Revogene SARS-CoV-2, Catalog 410700: Laboratorys should consider evaluating patient test results per laboratory policies and procedures. Review current inventory and segregate any remaining stock. Contact Meridian Technical Support 800.343.3858 to obtain a FedEx label to return any remaining unexpired inventory to Meridian Bioscience Inc. Any expired inventory should be destroyed in accordance with facility protocols. Complete and return the Customer Notification Form. This will indicate receipt of this field correction notice. Revogene RNA Software Upgrade Kit, Catalog 610240: Review current inventory and segregate any remaining stock of the RNA Software kit, including the USB. Contact Meridian Technical Support 800.343.3858 to obtain a FedEx label to return remaining unexpired inventory to Meridian Bioscience, Inc. Any expired inventory should be destroyed in accordance with facility protocols. Complete and return the Customer Notification Form. This will indicate receipt of this field correction notice. Actions to Be Taken By Meridian: Meridian intends to conduct additional validation and bridging studies with the intention of re-submitting an EUA application for its SARS-CoV-2 test on the Revogene platform as soon as possible thereafter. Contact Information: If you have any questions, please call Meridian Bioscience Technical Services at 1-800-343-3858, or email at MBI-TechService@meridianbioscience.com.
Quantity in Commerce 124 Revogene RNA Software Upgrade Kits
Distribution Nationwide
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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