FDA-Device2021-04-21Class II
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
Vectornate USA Inc
Hazard
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
Sold states
US Nationwide distribution in the state of NJ.
Affected count
130,000 devices
Manufactured in
10 Industrial Ave Ste 4, N/A, Mahwah, NJ, United States
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 specimens containing viruses, from the collection site to the testing laboratory. I
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1417-2021Don't want to check this manually?
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