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Radiometer America Inc recalls AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Recalled February 10, 2016 · FDA recall Z-0748-2016 · Radiometer America
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. · FDA Class II
Units
375
Sold at
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 Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.
Description
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.
Product
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Manufacturer(s)
Radiometer America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →