Z-1046-2015 Class II Terminated
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
ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
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.
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.
Code Information
Model number 393-090 (instrument). The affected analyzers are serial numbers 393-090R0027N001 to present.