Reported Feb 16, 2022 · Terminated

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Gentueri Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Gentueri Inc · 312 Locust Dr · Verona, WI · 53593-2215

Is this the product you have?

  • Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Lot codes and dates
    • CAT#: 3300-000
    • Lot No.: 1029
Amount recalled
13,975 units (2 mL in a 15 mL conical tube)

Where it was sold

Why it was recalled

Kits failed sterility testing and showed evidence of contamination.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 12, 2023 · Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.