Gentueri Viral Transport Medium Kit recalled due to sterility failure
Gentueri Inc is recalling Viral Transport Medium Kits due to failed sterility testing and evidence of contamination. The recall affects 13,975 units distributed to Illinois, Nebraska, and Wisconsin.
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 is an FDA Class II medical device recall for a product that failed sterility testing and showed evidence of contamination, presenting a risk of harm in specimen collection. No illnesses or injuries have been reported.
Plain-English summary
Gentueri Inc is recalling the Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab due to failed sterility testing and evidence of contamination detected during manufacturing.
The affected product consists of viral transport medium in 2 mL volumes contained in 15 mL conical tubes. A total of 13,975 units have been recalled under lot number 1029 (CAT#: 3300-000).
Distribution was limited to healthcare and diagnostic facilities in Illinois, Nebraska, and Wisconsin. Consumers and healthcare providers who have received this product should not use it. Contact Gentueri Inc for instructions on proper disposal and potential replacement.
The recalled product
- Product
- Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
- Manufacturer
- Gentueri Inc
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 No.: 1029.
Distribution
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