Device 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
Z-1417-2021
Product summary
- Event
- Event 87575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 130,000 devices
- Official record key
device-enforcement:Z-1417-2021
Official wording
Reason: Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
Code information: Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076
Distribution pattern: US Nationwide distribution in the state of NJ.
Derived failure modes
-
Unknown
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.