FDA Device

ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.

Hazard

ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.

What You Should Do

Remedy

The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.

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Products

ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
Brand
Radiometer America Inc
UPC
All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx

Units Affected

36

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