AVOXimeter 1000E (Accriva) – Calibration Value Inaccuracy (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Brand
Accriva Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI: 10711234530023. Serial Number: 6824
Products Sold
UDI-DI: 10711234530023. Serial Number: 6824
Accriva Diagnostics, Inc. is recalling AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whol due to Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 9/27/24, a recall notice was sent to a customer informing them to do the following: 1) This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where the potentially affected device has been transferred.. 2. Call Technical Support 1-800-678-0710 to initiate a Service Call and Returned Material Authorization 3. Complete and return the customer response form via email to For technical questions contact Technical Support at the number above or email techsupport.na@werfen.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ
Page updated: Jan 10, 2026