Meridian Bioscience Inc: Medical Device Recall in 2021 - (Recall #: Z-1540-2021)

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 SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19

Product Classification:

Class II

Date Initiated: April 8, 2021

Date Posted: May 19, 2021

Recall Number: Z-1540-2021

Event ID: 87556

Reason for Recall:

Emergency Use Application (EUA) application withdrawn as false negative results reported

Status: Terminated

Product Quantity: 376 kits of the Revogene SARS-CoV-2 assay

Code Information:

All lot numbers

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated