Recall Z-1109-2022 ยท PEP Molecular Erythrocyte Typing Test
Luminex Corporation
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
| Date | Feb 15, 2022 |
| Status | Open, Classified |
| Reason | Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot. |
| Root cause | Under Investigation by firm |
| Action | Luminex sent a product recall notice on 02/15/2022 by email. The notice informed the user of "No Call Internal Control failures" and requested that they contact Luminex Global Support Services at support@luminexcorp.com to arrange for replacement and confirm the disposal of any kits in inventory. |
| Quantity | 984 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) Nanosphere, Inc., Jan 8, 2014 |