Recall Z-0279-2025— Accriva Diagnostics, Inc.
Class II · Completed
Class II FDA medical device recall by Accriva Diagnostics, Inc., initiated 2024-09-27. It names one FDA 510(k) clearance: K922075. Product: AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.. Reason: 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..
- Recalling firm
- Accriva Diagnostics, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2024-09-27
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.