Blood Oximeter Calibration Error Causes Inaccurate Oxygen Readings
The AVOXimeter 1000E blood oximeter (Serial Number 6824) has calibration values that are higher than normal, causing false oxygen level readings. This may lead to patient care mismanagement based on inaccurate data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (blood oximeter) with potential for serious patient harm through medical mismanagement based on inaccurate readings. No illnesses or injuries have been reported in the source. As a Class II recall with theoretical hazard and no reported harm, the score is 3 per the rubric.
Plain-English summary
The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter manufactured by Accriva Diagnostics, Inc. The recalled unit, with Serial Number 6824, is subject to a Class II recall due to a calibration error that impacts patient safety.
The device's calibration values have been observed to be higher than normal. This causes the oximeter to display blood oxygen levels that are higher than the patient's actual oxygen saturation. Caregivers relying on these inflated readings may make incorrect clinical decisions, potentially leading to patient care mismanagement and the need for medical intervention based on false data.
The affected unit was distributed in Arizona.
The recalled product
- Product
- AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
- Manufacturer
- Accriva Diagnostics, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 10711234530023. Serial Number: 6824
Distribution
Distributed in 1 state:
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