Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA device recall Z-0568-2026 · posted 2025-11-19 · Open, Classified
Recall details
- Recalling firm
- Meridian Bioscience Inc
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- OMN
- Quantity affected
- 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.
- Date initiated
- 2025-10-07
- Date posted
- 2025-11-19
- Location
- Cincinnati, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (K110012) | Meridian Bioscience, Inc. | 2011-02-24 |