Z-1046-2015 Class II Terminated
FDA device recall Z-1046-2015 was initiated by Radiometer America Inc on December 8, 2014 and is designated Class II. Reason for recall: The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result. The recall status is terminated (terminated September 23, 2015). Affected quantity: 5002 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2015
- Initiation Date
- December 8, 2014
- Termination Date
- September 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5002 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution -USA including CT, MN, FL, CA, PA, NY, KY, MA, WA, MI, TX, NC, IL, OH, SC, OK, NJ, MD, VA, UT, AL, NM, GA, LA, OR, IN, WI, AZ, ND, CO, MO, WV, ID, TN, VT, NE, IA, NH, MS, ME, AR and Internationally to Canada, Australia, Austria , China, Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovenia, United Arab Emirates, Bolivia, Brazil, Indonesia, Israel, Kuwait, Malaysia, Mexico, Peru, Qatar, Saudi Arabia, Serbia and Montenegro, Syrian Arab Republic, Thailand, Vietnam, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Republic of Korea, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.