AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Summary
The FDA issued a Class II for AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-o by Accriva Diagnostics, Inc.. Reason: Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where .
Details
Source
Device Recall
External ID
Z-0279-2025
Action Date
2024-11-06
Status
Completed
Category
device
Product Description
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Lot/Code Info: UDI-DI: 10711234530023. Serial Number: 6824
Quantity Affected: 1
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.
Distribution
US: AZ
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-27
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Accriva Diagnostics, Inc. has 8 FDA actions in our database, including 6 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accriva Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accriva Diagnostics, Inc. have FDA actions?
Accriva Diagnostics, Inc. has 8 FDA actions in our database, including 6 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0279-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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