Meridian Bioscience Inc: Medical Device Recall in 2026 - (Recall #: Z-1019-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

Product Classification:

Class II

Date Initiated: December 5, 2025

Date Posted: January 14, 2026

Recall Number: Z-1019-2026

Event ID: 98038

Reason for Recall:

The affected lots show a decline in performance over time, which may lead to false-negative results.

Status: Ongoing

Product Quantity: 211 units

Code Information:

UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201

Distribution Pattern:

US Nationwide distribution and the OUS country of Italy.

Voluntary or Mandated:

Voluntary: Firm initiated