Recall Z-1417-2021 ยท JSG Culture Media, Non-Selective And Non-Differential
Vectornate USA Inc
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
| Date | Feb 16, 2021 |
| Status | Terminated |
| Reason | Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 130,000 devices |
| Distribution | US Nationwide distribution in the state of NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.