Meridian Bioscience Inc recalls Revogene C. difficile

The affected lots show a decline in performance over time, which may lead to false-negative results.

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

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.

• FDA enforcement recordOfficial FDA database entry for Z-1019-2026
• FDA 510(k) clearance · K172569The device's official FDA premarket clearance record
• FDA device classification · OZNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3130The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Meridian Bioscience IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.