AUTION HYBRID AU-4050
FDA Device Recall #Z-1850-2019 — Class II — May 3, 2019
Recall Summary
| Recall Number | Z-1850-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 3, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arkray Factory USA, Inc. |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 159 units |
Product Description
AUTION HYBRID AU-4050
Reason for Recall
This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.
Distribution Pattern
US
Lot / Code Information
UDI: (01) 00015482146030 All serial numbers
Other Recalls from Arkray Factory USA, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0631-2016 | Class I | arkray SPOTCHEM II Basic Panel - 1 Reagent test... | Dec 18, 2015 |
| Z-0630-2016 | Class I | arkray SPOTCHEM II Glucose Reagent test strips,... | Dec 18, 2015 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.