Class II — Accriva Diagnostics, Inc.
| Recalling firm | Accriva Diagnostics, Inc. |
|---|---|
| Registered facility | Accriva Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| Product | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. |
| Quantity | 1 |
| Distribution | US: AZ |
| Initiated | 2024-09-27 |
| Classified | 2024-10-31 |
| Recall number | Z-0279-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Accriva Diagnostics, Inc. (Z-0279-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95497/
Alerts for Accriva Diagnostics, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.