FDA-Device2016-02-10Class II
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Radiometer America Inc
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.
Sold states
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.
Affected count
375
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0748-2016Don't want to check this manually?
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