Recall Z-0504-2022— Gentueri Inc

Name: FDA recall Z-0504-2022
Creator: U.S. Food and Drug Administration
Published: 2021-03-18

Class II · Terminated

Class II FDA medical device recall by Gentueri Inc, initiated 2021-03-18, terminated 2023-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Gentueri Viral Transport Medium (VTM), Sterile, IVD. Reason: Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing..

Recalling firm: Gentueri Inc
Classification: Class II
Status: Terminated
Initiated: 2021-03-18
Terminated: 2023-08-28
Firm location: Verona, WI, United States

Product description

Gentueri Viral Transport Medium (VTM), Sterile, IVD

Reason for recall

Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.