Recall Z-1488-2021— Luminex Corporation

Name: FDA recall Z-1488-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-18

Class II · Ongoing

Class II FDA medical device recall by Luminex Corporation, initiated 2021-03-18. It names one FDA 510(k) clearance: K140083. Product: VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.. Reason: Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-03-18
Firm location: Northbrook, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)Nanosphere, Inc.·cleared 2014-06-20

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 Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

Reason for recall

Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

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