Meridian Bioscience Inc: Medical Device Recall in 2021 - (Recall #: Z-1541-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 8, 2021

Date Posted: May 19, 2021

Recall Number: Z-1541-2021

Event ID: 87556

Reason for Recall:

Emergency Use Application (EUA) application withdrawn as false negative results reported

Status: Terminated

Product Quantity: 124 Revogene RNA Software Upgrade Kits

Code Information:

All lot numbers

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated