FDAFDA · Food and drugs·Recall number Z-1582-2018
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of 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 the user 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.
Published May 9, 2018 · Recall initiated: February 27, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Radiometer Medical ApS
- Distributor
- US Nationwide Distribution in the states to Georgia and Wisconsin.
- Lot
- Version 2.3.0 and 2.3.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Denmark
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