The Recall Desk
HighFDA (Devices)·Z-0504-2022·Announced 2022-01-26

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.

What this means for you

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
Hazard
  • contamination
  • sample-integrity

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

Distributed nationwide across the United States.

Related recalls

Same category