Recall Z-0504-2022 ยท JSM Culture Media, Non-Propagating Transport
Gentueri Inc
Gentueri Viral Transport Medium (VTM), Sterile, IVD
| Date | Mar 18, 2021 |
| Status | Terminated |
| Reason | Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing. |
| Root cause | Environmental control |
| Action | The firm called the customer on 03/19/2021 and indicated that there was a possible contamination of Lot 1142 and that this needed to be held at distribution facilities. Following the conversation, Gentueri emailed as an attachment a "Removal Notification," for VTM Lot 1142 that explained that the lot failed to pass inspection and all product from this lot at the customer's site needed to be returned. Customers with any questions are to contact Gordon S. Hunter, Marketing Manager for Gentueri, at ghunter@gentueri.com or 1-608-497-0366. |
| Quantity | 4,150 units |
| Distribution | US Nationwide distribution in the state of Indiana. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.