Recall Z-0920-2022
Luminex Corporation · initiated April 22, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Codes / lots: Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010
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 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.
Details
- Recall number
- Z-0920-2022
- Initiated
- April 22, 2019
- Product code
- NSU – Instrumentation For Clinical Multiplex Test Systems
- Quantity
- 4 units
- Distribution
- US: TX, CT, LA
- Recalling firm
- Luminex Corporation, Northbrook, IL