FDAFDA · Food and drugs·Recall number Z-0279-2025
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Published November 6, 2024 · Recall initiated: September 27, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Accriva Diagnostics, Inc.
- Distributor
- US: AZ
- Lot
- UDI-DI: 10711234530023. Serial Number: 6824
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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