Recall Z-1092-2022 ยท OOI Real Time Nucleic Acid Amplification System
Luminex Corporation
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
| Date | May 13, 2022 (initiated Apr 5, 2022) |
| Status | Open, Classified |
| Reason | Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results. |
| Root cause | Under Investigation by firm |
| Action | On 04/21/22 Luminex issued a "Urgent Medical Device Recall" Notification to affected consignees. On 6/16/22 and 7/14/22 Luminex expanded the recall to include additional serial numbers. Luminex is asking consignees to take the following actions: 1. Continue use of your VERIGENE Processor SP as service has been completed by a Luminex Field Service Engineer and the Processor SP s heaters are now within specification. 2. Perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture (BC-GP) and VERIGENE Gram-Negative Blood Culture (BC-GN) Nucleic Acid Tests from 18 months |
| Quantity | 24 units |
| Distribution | US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None |
| 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 |