Recall – False negative reports from automated molecular platform

Company: Meridian Bioscience Inc
Date of Enforcement Report: 5/19/2021
Class II

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.

Recall Number: Z-1541-2021

REASON

Emergency Use Application (EUA) application withdrawn as false negative results reported.

RECALLING FIRM/MANUFACTURER

Meridian Bioscience Inc on 4/8/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

124 Revogene RNA Software Upgrade Kits

DISTRIBUTION

U.S. Nationwide

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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