Recall Z-2010-2021— Luminex Corporation

Name: FDA recall Z-2010-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-30

Class II · Ongoing

Class II FDA medical device recall by Luminex Corporation, initiated 2020-10-30. It names one FDA 510(k) clearance: K123197. Product: Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022. Reason: Potential for a false-negative result..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-10-30
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 Kit (CDF) Model Number: 20-006-022

Reason for recall

Potential for a false-negative result.

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