Recall Z-0920-2022 ยท NSU Instrumentation For Clinical Multiplex Test Systems
Luminex Corporation
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
| Date | Apr 22, 2019 |
| Status | Open, Classified |
| Reason | Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question. |
| Root 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 | 4 units |
| Distribution | US: TX, CT, LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.