Alethia C. Difficile Test (Meridian) – tube cap defect (2025)
Hazard assessment based on recall description.
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
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Brand
Meridian Bioscience Inc
Lot Codes / Batch Numbers
UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01, 480050U037, Exp. 2026-09-04
Products Sold
UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04
Meridian Bioscience Inc is recalling Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test A due to The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CO, FL, GA, IL, ME, MD, MT, NH, NJ, OH, TN, TX, WA
Page updated: Jan 10, 2026