Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AVOXimeter 1000E Recalled by Accriva Diagnostics, Inc. Due to Values used to calibrate whole blood oximeter instruments...

Date: September 27, 2024
Company: Accriva Diagnostics, Inc.
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Accriva Diagnostics, Inc. directly.

Affected Products

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

Quantity: 1

Why Was This 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.

Where Was This Sold?

This product was distributed to 1 state: AZ

Affected (1 state)Not affected

About Accriva Diagnostics, Inc.

Accriva Diagnostics, Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report