Medical device recalls Moderate risk

Gentueri Inc recalls Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Recall date
July 6, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0561-2022
FDA classification
Class II
Brand / firm
Gentueri Inc
Sold / distributed
Domestic: Illinois, Nebraska, and Wisconsin.

Why it was recalled

Kits failed sterility testing and showed evidence of contamination.

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 Kit with 8cm Breakpoint Swab

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