Reported Mar 13, 2013 · Terminated

Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as…

Beckman Coulter 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: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Lot codes and dates
  • All serial numbers and all software versions 4.05 and prior. Part# Item#
    • A94907
    • AU5811-02
    • A94912
    • AU5821-02
    • A94917
    • AU5831-02
    • A94922
    • AU5841-02
    • A94908
    • AU5811-03
    • A94913
    • AU5821-03
    • A94918
    • AU5831-03
    • A94923
    • AU5841-03
    • A94909
    • AU5811-04
    • A94914
    • AU5821-04
    • A94919
    • AU5831-04
    • A94924
    • AU5841-04
    • A94910
    • AU5811-06
    • A94915
    • AU5821-06
    • A94920
    • AU5831-06
    • A94925
    • AU5841-06
Amount recalled
28 in U.S.; 4 Canada; 318 to other foreign countries.

Where it was sold

  • Nationwide

Why it was recalled

Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.

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 Feb 24, 2014 · Data as of Sep 19, 4:52 PM UTC

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