Z-1417-2021Class II

MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL...

Name: Z-1417-2021 MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL...
Creator: Vectornate USA Inc
Published: 2021-02-16
License: https://open.fda.gov/license/

Vectornate USA Inc / initiated 2021-02-16 / Terminated / root cause: manufacturing process

FDA source

Vectornate USA Inc began a recall of MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for... on 2021-02-16. FDA classified it as Class II and gives the reason as "Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1417-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-16
Posted: 2021-04-13
Terminated: 2022-12-08
Recalling firm: Vectornate USA Inc
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
Product code: JSG Culture Media, Non-Selective And Non-Differential
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 130,000 devices
Distribution: US Nationwide distribution in the state of NJ.
Product codes and lots: Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1417-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1417-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-13

Product code JSG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)