FDA Medical devices recall ·
Meridian Bioscience, alethia c recall
- Recall number
- Z-0568-2026
- Date
- (initiated October 7, 2025)
- Company / brand
- Meridian Bioscience Inc
3471 River Hills Dr, Cincinnati, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 109 in total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Why was it recalled?
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04
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.
States: Alabama Colorado Florida Georgia Illinois Maryland Maine Montana New Hampshire New Jersey Ohio Tennessee Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0568-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.