FDAFDA · Food and drugs·Recall number Z-0816-2014
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.
Published January 29, 2014 · Recall initiated: October 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Radiometer America Inc
- Distributor
- 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.
- Lot
- Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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