Reported Dec 28, 2016 · Terminated
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE…
Radiometer America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer America Inc · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- AQURE System Software Version 2.2.0 Model #: 933-599
- UDI(01)05700699335999(10)2.2.0
- Catalog number933-599 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 useThe 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
- Lot codes and dates
- UDI(01)05700699335999(10)2.2.0
- Amount recalled
- 7 total (2 in US)
Where it was sold
Why it was recalled
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
This product could cause temporary or reversible health problems — stop using it.
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