Reported May 9, 2018 · Terminated
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of…
Radiometer Medical ApS
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 Medical ApS · Akandevej 21 · Bronshoj, N/A · N/A
Is this the product you have?
- AQURE, Software version 2.3.0 and 2.3.1
- Product UsageThe 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
- Lot codes and dates
- Version 2.3.0 and 2.3.1
- Amount recalled
- 2
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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