Drug recall
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood…
FDA recall event 95497 · Class II · Accriva Diagnostics, Inc.
Key facts
| Event ID | 95497 |
|---|---|
| Recall numbers | Z-0279-2025 |
| Recalling firm | Accriva Diagnostics, Inc. |
| Product type | Devices |
| Products | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 27, 2024 |
| Report date | Nov 6, 2024 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2250033 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: