Vectornate USA Inc recalls MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTU…

Recall date

February 16, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1417-2021

FDA classification

Class II

Brand / firm

Vectornate USA Inc

Sold / distributed

US Nationwide distribution in the state of NJ.

Why it was recalled

Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.

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

What was recalled

MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I