Recall Z-0054-2021 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Luminex Corporation
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
| Date | Dec 10, 2018 |
| Status | Open, Classified |
| Reason | No results/incorrect results due to failure of the hybridization heater. |
| Root cause | Component design/selection |
| Action | On or about 11/19/2018 there was one complaint from a customer regarding a thermal control failure. In response to the complaint the Field Service Engineer replaced hybridization heater and ran all tests as passed. Subsequently, the customer reported the initial service was ineffective. The VERIGENE SP Processor was then removed from the customer site and returned for analysis. No Customer Notification was communicated for this removal. |
| Quantity | 1 system |
| Distribution | US distribution in MO. No OUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Nanosphere, Inc., Sep 4, 2015 |