FDA recall Z-1417-2021

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the state of NJ.

Key facts

Status

Terminated

Initiation date

2021-02-16

Report date

2021-04-21

Termination date

2022-12-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1417-2021