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U.S. Department of Health and Human Services

Class 2 Device Recall Revogene C. difficile

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 Class 2 Device Recall Revogene C. difficilesee related information
Date Initiated by FirmDecember 05, 2025
Date PostedJanuary 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1019-2026
Recall Event ID 98038
510(K)NumberK172569 
Product Classification C. Difficile toxin gene amplification assay - Product Code OZN
ProductRevogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Code Information UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244-3023
For Additional Information ContactHeather Capito
800-343-3858
Manufacturer Reason
for Recall		The affected lots show a decline in performance over time, which may lead to false-negative results.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn "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 FieldActionSupport@meridianbioscience.com.
Quantity in Commerce211 units
DistributionUS Nationwide distribution and the OUS country of Italy.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OZN
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