Recall Z-0477-2021 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
| Date | Oct 13, 2020 |
| Status | Terminated |
| Reason | Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/13/2020, the firm sent the following notice: "As part of our corrective action plan, Luminex will be updating software on all VERIGENE SP instruments in the coming weeks, and systematically visiting every VERIGENE customer site to perform a supplemental preventative maintenance on your instruments. We will also likely be sending out a series of Customer Advisory Notifications with additional information on items related to our remediation efforts surrounding the Warning Letter, as well as updates related to other items identified for improved product performance. During this time, you ma |
| Quantity | 2838 units |
| Distribution | Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey |
| 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 |