Reported Nov 6, 2024 · Completed
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Accriva Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accriva Diagnostics, Inc. · 6260 Sequence Dr · San Diego, CA · 92121-4358
Is this the product you have?
- AVOXimeter 1000E
- Product NumberAVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter
- Lot codes and dates
- UDI-DI10711234530023
- Serial Number6824
- Amount recalled
- 1
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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