FDAHealthOctober 7, 2025
Meridian Bioscience Inc — Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
⚠️ The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Is this relevant to me?
- Geography
- US, AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX, WA
- Source agency
- FDA
- Category
- Health
- Published
- October 7, 2025
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.
What's affected?
- Product
- Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
- Lot code
- 480050U036
Additional details
UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 109 in total.
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