Vectornate USA Inc Recall 87575
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
Vectornate USA Inc Recall 87575 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1417-2021 |
| Event ID | 87575 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of NJ. |
| Quantity | 130,000 devices |
| Recall Reason | Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility. |
| Device Classification | 20210421 |
| Device Code Info | Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076 |
| Center Classification Date | 20210413 |
| Recall Initiation Date | 20210216 |
| Recalling Firm | Vectornate USA Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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