Z-0836-2022Class II

Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian...

Name: Z-0836-2022 Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian...
Creator: Meridian Bioscience Inc
Published: 2022-02-15
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2022-02-15 / Open, Classified / root cause: design

FDA source

Meridian Bioscience Inc began a recall of Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC... on 2022-02-15. FDA classified it as Class II and gives the reason as "The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0836-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-15
Posted: 2022-03-30
Recalling firm: Meridian Bioscience Inc
Product: Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
Root cause tag: design
FDA root cause: Component design/selection
Action: A Letter dated 02/15/2022 sent via FedEx notified users of the risk of false-positives and provided instructions on how to recognize a compromised photomultiplier tube via error codes and based on various combinations of positive and indeterminate results. If a positive result with the negative control is obtained or false positive suspected, users are to contact Technical Service and cease using the instrument. The company is developing software solution aimed at identifying photomultiplier tubes that are at risk for failure and is seeking a hardware fix to this issue.
Quantity in commerce: 452 units (398 US, 54 OUS)
Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Chile, Italy, Switzerland.
Product codes and lots: UDI: 00840733102318 All units in the field, all serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0836-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0836-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-30

Product code OOI

K170558Class IIrevogeneGenepoc, Inc. / cleared 2017-05-25

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)