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FDA (Device enforcement)Recalled 2025-10-07class ii

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

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.

Details from the source

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. 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. Quantity: 109 in total Lot/code info: UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04

UPC codes

00840733102172

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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