Medical device recalls Moderate risk

Gentueri Inc recalls Gentueri Viral Transport Medium (VTM), Sterile, IVD

Recall date
March 18, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0504-2022
FDA classification
Class II
Brand / firm
Gentueri Inc
Sold / distributed
US Nationwide distribution in the state of Indiana.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Gentueri Viral Transport Medium (VTM), Sterile, IVD

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