Z-0748-2016 Class II Terminated
FDA device recall Z-0748-2016 was initiated by Radiometer America Inc on December 29, 2015 and is designated Class II. 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 … The recall status is terminated (terminated March 29, 2016). Affected quantity: 375.
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
Reason for Recall
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.