AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catal...
FDA Device Recall #Z-0899-2017 — Class II — November 23, 2016
Recall Summary
| Recall Number | Z-0899-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 23, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Radiometer America Inc |
| Location | Brea, CA |
| Product Type | Devices |
| Quantity | 7 total (2 in US) |
Product Description
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
Reason for Recall
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Distribution Pattern
Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
Lot / Code Information
UDI: (01)05700699335999(10)2.2.0
Other Recalls from Radiometer America Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2320-2019 | Class II | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | Jul 10, 2019 |
| Z-0682-2019 | Class II | ABL800 analyzer, model numbers 393-800 and 393-... | Jul 3, 2018 |
| Z-0801-2019 | Class II | Product: ABL800 FLEX with Crea. The ABL800 with... | Jul 2, 2018 |
| Z-0010-2019 | Class II | ABL90 FLEX analyzers with software versions 3.3... | May 25, 2018 |
| Z-0231-2018 | Class II | ABL800 analyzer with FLEXQ module. Device in... | Oct 24, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.