Luminex Corporation: Medical Device Recall in 2023 - (Recall #: Z-2024-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

Product Classification:

Class II

Date Initiated: June 5, 2023

Date Posted: July 5, 2023

Recall Number: Z-2024-2023

Event ID: 92451

Reason for Recall:

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

Status: Ongoing

Product Quantity: 114 units

Code Information:

UDI/DI , Lot Numbers: 071222022D, 100622022D

Distribution Pattern:

Worldwide and US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated