Meridian Bioscience Inc: Medical Device Recall in 2025 - (Recall #: Z-0568-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 7, 2025

Date Posted: November 26, 2025

Recall Number: Z-0568-2026

Event ID: 97787

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.

Status: Ongoing

Product Quantity: 109 in total

Code Information:

UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated