FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1417-2021
- 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
- Status
- Terminated
- Initiated
- 2021-02-16
- Posted
- not on file
- Terminated
- 2022-12-08
- 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.
- Lot, serial or model codes
- Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSG
- Firm FEI
- 3015989005
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28