Z-0279-2025 Class II
FDA device recall Z-0279-2025 was initiated by Accriva Diagnostics, Inc. on September 27, 2024 and is designated Class II. Reason for recall: 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, whic… Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- September 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Reason for Recall
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.
Distribution Pattern
US: AZ
Code Information
UDI-DI: 10711234530023. Serial Number: 6824