FDAAugust 8, 2019device
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.
What to do
FDA enforcement status: Terminated
Brands named
radiometer medical apsradiometerradiometer medical
UPCs
05700699335999
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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