FDA-Device2022-01-26Class II

Gentueri Viral Transport Medium (VTM), Sterile, IVD

Gentueri Inc
Hazard

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

Sold states
US Nationwide distribution in the state of Indiana.
Affected count
4,150 units
Manufactured in
312 Locust Dr, N/A, Verona, WI, United States
Products
Gentueri Viral Transport Medium (VTM), Sterile, IVD

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2022

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