Recall Z-0568-2026— Meridian Bioscience Inc

Name: FDA recall Z-0568-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-07

Class II · Ongoing

Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2025-10-07. It names one FDA 510(k) clearance: K110012. Product: Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay. Reason: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume..

Recalling firm: Meridian Bioscience Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-10-07
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K110012 — ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10Meridian Bioscience, Inc.·cleared 2011-02-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.