Z-0568-2026Class II

Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Name: Z-0568-2026 Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Creator: Meridian Bioscience Inc
Published: 2025-10-07
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2025-10-07 / Open, Classified / root cause: manufacturing process

FDA source

Meridian Bioscience Inc began a recall of Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay on 2025-10-07. FDA classified it as Class II and gives the reason as "The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0568-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-07
Posted: 2025-11-19
Recalling firm: Meridian Bioscience Inc
Product: Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Product code: OMN C. Difficile Nucleic Acid Amplification Test Assay
Reason for recall: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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: [email protected]. 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 [email protected].
Quantity in commerce: 109 in total
Distribution: US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.
Product codes and lots: UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0568-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0568-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-19
Z-0569-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-19

Product code OMN

K110012Class IIllumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc. / cleared 2011-02-24

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)