PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 21, 2021 Initiated: February 16, 2021 #Z-1417-2021

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.

Details

Recalling Firm
Vectornate USA Inc
Units Affected
130,000 devices
Distribution
US Nationwide distribution in the state of NJ.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Vectornate USA Inc. Units affected: 130,000 devices.
Why was this product recalled?
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1417-2021.