Reported Sep 17, 2014 · Terminated

RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to…

Radiometer America 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: Radiometer America Inc · 810 Sharon Dr · Westlake, OH · 44145-1521

Is this the product you have?

    • RADIANCE v. 2.4X
    • 2.5X and 2.6X
  • Product UsageRADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data
Lot codes and dates
    • Verions 2.4X
    • 2.5X and 2.6X
Amount recalled
N/A

Where it was sold

Why it was recalled

The notice does not describe the hazard.

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 Oct 15, 2014 · Data as of Sep 19, 5:22 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.