PlainRecalls
FDA Devices Moderate Class II Terminated

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Reported: February 16, 2022 Initiated: July 6, 2020 #Z-0561-2022

Product Description

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Reason for Recall

Kits failed sterility testing and showed evidence of contamination.

Details

Recalling Firm
Gentueri Inc
Units Affected
13,975 units (2 mL in a 15 mL conical tube)
Distribution
Domestic: Illinois, Nebraska, and Wisconsin.
Location
Verona, WI

Frequently Asked Questions

What product was recalled?
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab. Recalled by Gentueri Inc. Units affected: 13,975 units (2 mL in a 15 mL conical tube).
Why was this product recalled?
Kits failed sterility testing and showed evidence of contamination.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 16, 2022. Severity: Moderate. Recall number: Z-0561-2022.