Avoximeter Whole Blood Oximeter recallZ-0279-2025 · Accriva Diagnostics, Inc. · initiated Sep 27, 2024
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Accriva Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process change control
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0279-2025
- Status
- Completed
- Initiated by the company
- Sep 27, 2024
- Posted by the FDA
- Oct 31, 2024
- Recalling firm
- Accriva Diagnostics, Inc.
- Quantity
- 1
- Product code
- DQA
- FDA submissions
- K922075
- Distribution
- US: AZ
Product description
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Code information (models, lots, serial numbers)
UDI-DI: 10711234530023. Serial Number: 6824
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Avoximeter Whole Blood Oximeter AVOX1000EAccriva Diagnostics Holdings, Inc. · Oximeter1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K922075 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Avoximeter Whole Blood Oximeter C100BAccriva Diagnostics Holdings, Inc. · Oximeter1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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