Gentueri Viral Transport Medium Recalled Due to Turbidity and Discoloration
Gentueri Inc is recalling 4,150 units of Gentueri Viral Transport Medium (VTM) nationwide due to visual turbidity and discoloration that may compromise diagnostic samples in transit.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic device with visual contamination (turbidity and discoloration) that could compromise sample integrity. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Gentueri Inc is recalling 4,150 units of Gentueri Viral Transport Medium (VTM), Sterile, IVD (Lot #1142, CAT #3300-000), which is used to collect and preserve samples for laboratory diagnostic testing.
The recall was initiated because the product exhibited visual turbidity and discoloration that could potentially contaminate samples during transport. This may compromise the integrity of diagnostic test results.
The affected units were distributed nationwide in the state of Indiana.
Healthcare facilities and laboratories that received this product should discontinue use and contact Gentueri Inc for return or replacement instructions.
The recalled product
- Product
- Gentueri Viral Transport Medium (VTM), Sterile, IVD
- Manufacturer
- Gentueri Inc
- Category
- Medical Device
- Affected units
- 4,150
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 (2)
- CAT #: 3300-000
- Lot #: 1142
Distribution
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