Z-1540-2021Class II

Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction...

Name: Z-1540-2021 Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction...
Creator: Meridian Bioscience Inc
Published: 2021-04-08
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2021-04-08 / Terminated

FDA source

Meridian Bioscience Inc began a recall of Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene... on 2021-04-08. FDA classified it as Class II and gives the reason as "Emergency Use Application (EUA) application withdrawn as false negative results reported". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1540-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-08
Posted: 2021-05-07
Terminated: 2021-10-26
Recalling firm: Meridian Bioscience Inc
Product: 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 code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: Emergency Use Application (EUA) application withdrawn as false negative results reported
FDA root cause: 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 [email protected].
Quantity in commerce: 376 kits of the Revogene SARS-CoV-2 assay
Distribution: Nationwide
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1540-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1540-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-07
Z-1541-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-07

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)