Vectornate Recalls MedSchenker Smart Transport Medium Due to Discoloration
Vectornate USA Inc is recalling 130,000 MedSchenker Smart Transport Medium systems due to discoloration and turbidity caused by a longer monsoon season at the manufacturing facility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality defect (discoloration/turbidity) without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Vectornate USA Inc is recalling 130,000 units of the MedSchenker Smart Transport Medium (STM) System. This product is a non-selective and non-differential multipurpose culture medium intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory.
The recall was initiated because discoloration and turbidity were present in the specified lots of STMs. The source text attributes this issue to a longer monsoon season at the South Korean manufacturing facility. The affected products were distributed nationwide in the United States, specifically within the state of New Jersey.
The affected units are identified by Serial Number STM-UNV-0001-Q121 and Lot Numbers JAH161 and KAG076. Consumers and healthcare facilities should stop using these specific lots and contact Vectornate USA Inc for further instructions.
The recalled product
- 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…
- Manufacturer
- Vectornate USA Inc
- Category
- Medical Device — Culture Media
- Affected units
- 130,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial #: STM-UNV-0001-Q121
- Lot #: JAH161
- KAG076
Distribution
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