Revogene C. difficile, in vitro diagnostic assay intended... (Meridian Bioscience Inc) – the affected lots show a decline in p... (2025)
This recall involves a product performance issue.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Brand
Meridian Bioscience Inc
Lot Codes / Batch Numbers
UDI-DI: 00840733102349, Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Products Sold
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Meridian Bioscience Inc is recalling Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Cata due to The affected lots show a decline in performance over time, which may lead to false-negative results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The affected lots show a decline in performance over time, which may lead to false-negative results.
Recommended Action
Per FDA guidance
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 FieldActionSupport@meridianbioscience.com.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.