Z-0279-2025Class II

AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood...

Name: Z-0279-2025 AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood...
Creator: Accriva Diagnostics, Inc.
Published: 2024-09-27
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2024-09-27 / Completed / root cause: manufacturing process

FDA source

Accriva Diagnostics, Inc. began a recall of AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter on 2024-09-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0279-2025
Classification: Class II
Status: Completed
Initiated: 2024-09-27
Posted: 2024-10-31
Recalling firm: Accriva Diagnostics, Inc.
Product: AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Product code: DQA 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.
Root cause tag: manufacturing process
FDA root cause: Process change control
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].
Quantity in commerce: 1
Distribution: US: AZ
Product codes and lots: UDI-DI: 10711234530023. Serial Number: 6824

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0279-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0279-2025	Class II	Completed	Voluntary: Firm initiated	2024-11-06	2024-10-31

Product code DQA

K922075Class IIAvoximeterA-Vox Systems, Inc. / cleared 1992-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)