Gentueri Inc Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Brand
Gentueri Inc
Lot Codes / Batch Numbers
CAT#: 3300-000, Lot No.: 1029.
Products Sold
CAT#: 3300-000; Lot No.: 1029.
Gentueri Inc is recalling Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab due to Kits failed sterility testing and showed evidence of contamination.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Kits failed sterility testing and showed evidence of contamination.
Recommended Action
Per FDA guidance
The firm distributed a notice to customers dated 07/06/2020 via email stating that lots 1029, 1029A, and 1029B need to be quarantined pending further investigation. Customers with questions are asked to contact Renee Schlick, Quality Assurance Manager, at 608-838-1640 or by email at rschlick@gentueri.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, NE, WI
Page updated: Jan 10, 2026