Recall Z-0279-2025 ยท DQA Oximeter
Accriva Diagnostics, Inc.
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
| Date | Oct 31, 2024 (initiated Sep 27, 2024) |
| Status | Completed |
| 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. |
| Root cause | Process change control |
| Action | On 9/27/24, a recall notice was sent to a customer informing them to do the following: 1) This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where the potentially affected device has been transferred.. 2. Call Technical Support 1-800-678-0710 to initiate a Service Call and Returned Material Authorization 3. Complete and return the customer response form via email to For technical questions contact Technical Support at the number above or email techsupport.na@werfen.com. |
| Quantity | 1 |
| Distribution | US: AZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922075 | AVOXIMETER A-Vox Systems, Inc., Nov 4, 1992 |