FDA-Device2022-02-16Class II
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Gentueri Inc
Hazard
Kits failed sterility testing and showed evidence of contamination.
Sold states
Domestic: Illinois, Nebraska, and Wisconsin.
Affected count
13,975 units (2 mL in a 15 mL conical tube)
Manufactured in
312 Locust Dr, N/A, Verona, WI, United States
Products
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0561-2022Don't want to check this manually?
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