Meridian Bioscience Inc recalls Meridian Bioscience

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

Meridian Bioscience issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees beginning on 10/15/2025 via email. The notice explained the problem with the device, health hazard, and requested the following: "Required Actions: " Identify remaining inventory of Alethia C. difficile, Lot 480050U036. " Identify the Reaction Buffer bag located within the kit box. " Remove Reaction Buffer Tubes from Bag and inspect each cap for the presence of a gasket. " Segregate Reaction Buffer Tubes which have no gasket present. Record the quantity of tubes with no gasket present on the CONFIRMATION OF NOTIFICATION Form. " Discard Reaction Buffer Tubes which have no gasket present in accordance with local, state, or federal regulations. Note: Execution of the test procedure requires the use of a Reaction Buffer tube. The remaining components in this kit may continue to be utilized for patient testing so long as a new Reaction Buffer tube is available. Once the Reaction Buffer is depleted, the remaining kit components must be discarded in accordance with local regulations. " Meridian Bioscience Inc. will provide credit for the number of tests impacted. " Complete and return the CONFIRMATION OF NOTIFICATION Form to: Product Support Manager, Meridian Bioscience, Inc., 3471 River Hills Drive, Cincinnati, OH 45244; Fax: (513) 272-5432 or Email: FieldActionSupport@meridianbioscience.com. Complete this form if there is no remaining inventory." For any question regarding this notification please call Meridian Bioscience Technical Services at 1-800-343-3858, or email at FieldActionSupport@meridianbioscience.com.

• FDA enforcement recordOfficial FDA database entry for Z-0569-2026
• FDA 510(k) clearance · K121044The device's official FDA premarket clearance record
• FDA device classification · NJROfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3740The 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.