Recall Z-1092-2022— Luminex Corporation

Name: FDA recall Z-1092-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-05

Class II · Ongoing

Class II FDA medical device recall by Luminex Corporation, initiated 2022-04-05. It names one FDA 510(k) clearance: K143653. Product: Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system. Reason: Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-04-05
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, Models 10-0000-07/10-0000-07R a component of the Verigene system

Reason for recall

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

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