Luminex Corporation Recall 89051
Description: Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Luminex Corporation Recall 89051 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0920-2022 |
Event ID | 89051 |
Event Description | Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R |
Product Type | Devices |
Distribution | US: TX, CT, LA |
Quantity | 4 units |
Recall Reason | Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question. |
Device Classification | 20220420 |
Device Code Info | Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010 |
Center Classification Date | 20220413 |
Recall Initiation Date | 20190422 |
Recalling Firm | Luminex Corporation |
Initial Notification | Visit |
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