FDA Device

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Hazard

Kits failed sterility testing and showed evidence of contamination.

What You Should Do

Remedy

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.

Products

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Brand
Gentueri Inc
UPC
CAT#: 3300-000; Lot No.: 1029.

Units Affected

13,975 units (2 mL in a 15 mL conical tube)