FDANovember 23, 2016device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

radiometer americaradiometer

UPCs

05700699335999

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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... — Recall Details · AllClear