Reported Feb 1, 2023 · Ongoing

Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog…

Meridian Bioscience 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: Meridian Bioscience Inc · 3471 River Hills Dr · Cincinnati, OH · 45244-3023

Is this the product you have?

  • Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection
  • of RNA from SARSCoV-2 Catalog Number410700
Lot codes and dates
  • UDI
    • N/A Lot Numbers 410700P019
    • 410700P020
    • 410700P021
    • 410700P022
    • 410700P023
    • 410700P024
    • 410700P027
Amount recalled
92 kits

Where it was sold

Why it was recalled

Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2

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

Data as of Sep 19, 6:55 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.