FDA Device

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

Hazard

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

What You Should Do

Remedy

The firm did not give out a public statement of a recall or recall strategy as it only affected one client and was specific to two identified lots. the firm did notify the customer of the issue via phone and email.

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Products

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
Brand
Vectornate USA Inc
UPC
Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076

Units Affected

130,000 devices

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