Class 2 Device Recall Verigene Processor SP

• Date Initiated by Firm: April 22, 2019
• Create Date: April 13, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0920-2022
• Recall Event ID: 89051
• Product Classification: Instrumentation for clinical multiplex test systems - Product Code NSU
• Product: Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
• Code Information: Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010
• FEI Number: 3006028115
• Recalling Firm/ Manufacturer: Luminex Corporation; 4088 Commercial Ave; Northbrook IL 60062-1829
• Manufacturer Reason for Recall: Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm sent technicians to sites beginning on 13 March 2019 to test the devices and the devices were subsequently returned. The firm send a notice regarding the recall on 03/10/2022 by email. The notices documented the actions of the firm with respect to the devices.
• Quantity in Commerce: 4 units
• Distribution: US: TX, CT, LA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.