Z-1019-2026Class II

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog...

Name: Z-1019-2026 Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog...
Creator: Meridian Bioscience Inc
Published: 2025-12-05
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2025-12-05 / Open, Classified

FDA source

Meridian Bioscience Inc began a recall of Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 on 2025-12-05. FDA classified it as Class II and gives the reason as "The affected lots show a decline in performance over time, which may lead to false-negative results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1019-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-05
Posted: 2026-01-05
Recalling firm: Meridian Bioscience Inc
Product: Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Product code: OZN C. Difficile Toxin Gene Amplification Assay
Reason for recall: The affected lots show a decline in performance over time, which may lead to false-negative results.
FDA root cause: Under Investigation by firm
Action: An "URGENT MEDICAL DEVICE CORRECTION" dated 12/1/25 was sent to customers. Required Actions: " Identify and segregate any remaining inventory of impacted product lots and suspend further use. " Destroy remaining inventory of impacted product lot in accordance with state, local, and/or federal regulations. o Contact Technical Service for replacement product. " Review previously obtained results from Revogene C. difficile listed Lots numbers. Any negative results obtained should be re-evaluated in conjunction with presented clinical findings to determine if retesting is required. " Complete and return the CONFIRMATION OF NOTIFICATION Form. Complete this form even if there is no remaining inventory. Actions to Be Taken By Meridian Bioscience, Inc.: Meridian Bioscience, Inc. will replace any unused inventory and provide support for any necessary retesting, including replacement test materials as needed. Contact Information: For any question regarding this notification please call Meridian Bioscience Technical Service at 1-800-343-3858, or email at [email protected].
Quantity in commerce: 211 units
Distribution: US Nationwide distribution and the OUS country of Italy.
Product codes and lots: UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1019-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1019-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-05

Product code OZN

K172569Class IIGenePOC CDiffGenepoc, Inc. / cleared 2017-11-22

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)