Recall Z-1417-2021— Vectornate USA Inc
Class II · Terminated
Class II FDA medical device recall by Vectornate USA Inc, initiated 2021-02-16, terminated 2022-12-08. FDA's recall record names no specific 510(k) clearance for this event. 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: Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility..
- Recalling firm
- Vectornate USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-16
- Terminated
- 2022-12-08
- Firm location
- Mahwah, NJ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.