Gentueri Viral Transport Medium (VTM), Sterile, IVD
FDA Recall Z-0504-2022 · Posted None
Recalling FirmGentueri Inc
Recall StatusTerminated
Product CodeJSM
Date Initiated2021-03-18
Date Terminated2023-08-28
Product Quantity4,150 units
Reason for Recall
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
Firm 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 [email protected] or 1-608-497-0366.
Root Cause
Environmental control
Distribution Pattern
US Nationwide distribution in the state of Indiana.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.