FDA-Device2024-11-06Class II
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Accriva Diagnostics, Inc.
Hazard
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.
Sold states
US: AZ
Affected count
1
Manufactured in
6260 Sequence Dr, N/A, San Diego, CA, United States
Products
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0279-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief