| Date Initiated by Firm |
February 16, 2021 |
| Create Date |
April 13, 2021 |
| Recall Status1 |
Terminated 3 on December 08, 2022 |
| Recall Number |
Z-1417-2021 |
| Recall Event ID |
87575 |
| Product Classification |
Culture media, non-selective and non-differential - Product Code JSG
|
| 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 |
| Code Information |
Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076 |
Recalling Firm/
Manufacturer |
Vectornate USA Inc
10 Industrial Ave Ste 4
Mahwah NJ 07430-2284
|
| For Additional Information Contact |
Shreya Patil
201-393-2973
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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 in Commerce |
130,000 devices |
| Distribution |
US Nationwide distribution in the state of NJ. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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