FDA Medical devices recall ·
AVOXimeter 1000E, Product Number: AVOX1000E… recall
- Recall number
- Z-0279-2025
- Date
- (initiated September 27, 2024)
- Company / brand
- Accriva Diagnostics, Inc.
6260 Sequence Dr, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 1
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10711234530023. Serial Number: 6824
Distribution
US: AZ
States: Arizona
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0279-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.