AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
FDA Recall Z-0279-2025 · Posted 2024-10-31
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Recalling FirmAccriva Diagnostics, Inc.
Recall StatusCompleted
Product CodeDQA
Date Initiated2024-09-27
Product Quantity1
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.
Firm Action
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].
Root Cause
Process change control
Distribution Pattern
US: AZ
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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