FDAFebruary 27, 2018device
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 po...
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
radiometer medical apsradiometerradiometer medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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