FDADecember 29, 2015device

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

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

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

radiometer americaradiometer

Recall history

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

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