FDA Enforcement
Class II
Completed
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Recall: Z-0279-2025
·
Reported November 6, 2024
Enforcement
- Recall Number
- Z-0279-2025
- Event ID
- 95497
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Accriva Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 6, 2024
- Initiation Date
- September 27, 2024
- Classification Date
- October 31, 2024
- Address
- 6260 Sequence Dr, N/A, San Diego, CA, 92121-4358, United States
Description
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Reason
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.
Code Info
UDI-DI: 10711234530023. Serial Number: 6824
Distribution
US: AZ
Quantity
1