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

Medical DevicesSource: FDA (device) · Date: 2025-11-26

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Meridian Bioscience Inc
Product
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Reason / hazard
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-10-07
Code info
UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04
Product quantity
109 in total
Voluntary mandated
Voluntary: Firm initiated
City
Cincinnati
State
OH
Country
United States
Event id
97787
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