medical Class II Updated 2020-02-05

Radiometer Medical ApS recalls AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (1

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software version 2.3.5 and below
View official government recall

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