Product Safety Recalls

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Luminex Corporation Recall 89051

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

Luminex Corporation Recall 89051 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0920-2022
Event ID89051
Event DescriptionVerigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Product TypeDevices
DistributionUS: TX, CT, LA
Quantity4 units
Recall ReasonTwo of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Device Classification20220420
Device Code InfoModel Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010
Center Classification Date20220413
Recall Initiation Date20190422
Recalling FirmLuminex Corporation
Initial Notification Visit
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