Z-1008-2023Class II

Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2...

Name: Z-1008-2023 Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2...
Creator: Meridian Bioscience Inc
Published: 2022-12-15
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2022-12-15 / Open, Classified / root cause: manufacturing process

FDA source

Meridian Bioscience Inc began a recall of Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700 on 2022-12-15. FDA classified it as Class II and gives the reason as "Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1008-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-15
Posted: 2023-01-20
Recalling firm: Meridian Bioscience Inc
Product: Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Meridian Bioscience issued Urgent Medical Device Recall on 12/15/22 via email. The letter states reason for recall, health risk and action to take: REQUIRED ACTIONS: " Inspect the rotor, ring, and chamber walls of the Revogene instrument for signs of leakage (e.g., dried spots). Contact Meridian Bioscience Technical Service if any signs of leakage were detected. " If leakage is suspected, clean the Revogene, MOCK PIEs, and surrounding workspace using the instructions in the Revogene operator's manual. " Review current inventory and segregate any remaining stock. " Discontinue use of any remaining stock. " Contact Meridian Technical Support 800.343.3858 to obtain a FedEx label to return any remaining inventory to Meridian Bioscience Inc. for credit. " Complete and return the Customer Notification Form. This will indicate receipt of this field correction notice. Complete this form even if you have no remaining inventory. Questions, please call Meridian Bioscience Technical Services at 1-800-343-3858, or email at [email protected].
Quantity in commerce: 92 kits
Distribution: US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.
Product codes and lots: UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1008-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1008-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-20

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)