Reported Feb 10, 2016 · Terminated

AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

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 · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • AQURE System
  • Model Number933-599. The AQURE System manages blood gas and immunoassay analyzers
Lot codes and dates
  • Model Number933-599 Version 1.8.3
Amount recalled
375

Where it was sold

Why it was recalled

The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.

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 Mar 29, 2016 · Data as of Sep 19, 6:00 PM UTC

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