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FDASeptember 27, 2024device

AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

What to do

FDA enforcement status: Completed

Brands named

accriva diagnosticsaccriva

UPCs

10711234530023

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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