Recall Z-1334-2022 ยท OZN C. Difficile Toxin Gene Amplification Assay
Luminex Corporation
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
| Date | Jun 17, 2022 |
| Status | Open, Classified |
| Reason | There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. |
| Root cause | Nonconforming Material/Component |
| Action | The firm notified its consignees of the recall by letter on 06/17/2022. The letter explained the issue and provided the following actions be taken: "Customer Action: 1. Please examine your inventory for the affected products, cease all use, and isolate or quarantine them pending disposal. 2. If you currently have any of the identified affected VERIGENE Stool Sample Preparation Kits in your possession (reference Tables 1 & 2 for impacted kit lots), please contact Luminex Global Support Services at support@luminexcorp.com to arrange for replacement and confirm the disposal of any remaining kits |
| Quantity | 296 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.