Recall Z-0054-2021— Luminex Corporation

Name: FDA recall Z-0054-2021
Creator: U.S. Food and Drug Administration
Published: 2018-12-10

Class II · Ongoing

Class II FDA medical device recall by Luminex Corporation, initiated 2018-12-10. It names one FDA 510(k) clearance: K143653. Product: VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids. Reason: No results/incorrect results due to failure of the hybridization heater..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Ongoing
Initiated: 2018-12-10
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc.·cleared 2015-09-04

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 Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

Reason for recall

No results/incorrect results due to failure of the hybridization heater.

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