Z-0816-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2014
- Initiation Date
- October 15, 2013
- Termination Date
- June 19, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total 3414 (US 524, CA 31, ROW 2859)
Product Description
ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Reason for Recall
RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
Distribution Pattern
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.
Code Information
Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010