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

Recall date

December 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0748-2016

FDA classification

Class II

Brand / firm

Radiometer America Inc

Sold / distributed

Worldwide Distribution-US (nationwide) including the states of PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdo…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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