Reported Jan 29, 2014 · Terminated

ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures…

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?

  • ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Lot codes and dates
    • Lot R0375N009
    • Model #393-090
    • S/N 393-090R0027N001 - 393-090R0379N010
Amount recalled
Total 3414 (US 524, CA 31, ROW 2859)

Where it was sold

Why it was recalled

RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) 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 Jun 19, 2014 · Data as of Sep 19, 5:22 PM UTC

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