Z-0748-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2016
- Initiation Date
- December 29, 2015
- Termination Date
- March 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 375
Product Description
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Model Number: 933-599 Version 1.8.3