RADIOMETER AMERICA INC

AQURE · General and Plastic Surgery

510(k): 0 Recall: 2 UDI: 0 MAUDE: 0 Class.: 0

Recalls (2)

AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to

2016-11-23

Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.

AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

2015-12-29

The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.