Recall Z-2024-2023— Luminex Corporation

Name: FDA recall Z-2024-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-05

Class II · Ongoing

Class II FDA medical device recall by Luminex Corporation, initiated 2023-06-05. It names one FDA 510(k) clearance: K123197. Product: VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022. Reason: 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..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-06-05
Firm location: Northbrook, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)Nanosphere, Inc.·cleared 2012-12-05

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

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

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.

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