RecallDepth

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

Company
Luminex Corporation
Recall Initiated
April 22, 2019
Recall Number
Z-0920-2022
Quantity
4 units
Firm Location
Northbrook, IL

Reason for Recall

Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.

Distribution

US: TX, CT, LA

Lot / Code Info

Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010;  Model Number 10-0000-07-R, Serial Numbers: 18079010

Root Cause

Under Investigation by firm

Action Taken

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.

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