medical Class II Updated 2024-11-06

Accriva Diagnostics, Inc. recalls AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ
Lot/Code Info: UDI-DI: 10711234530023. Serial Number: 6824
View official government recall

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