May

2021

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Emergency Use Application (EUA) application withdrawn as false negative results reported.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

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