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Recall Observatory FDA recall evidence

Device product

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.

Z-0816-2014

October 15, 2013

Class II

Product summary

Firm
Radiometer America Inc
Event
Event 66875
Status
Terminated
Classification
Class II
Quantity
Total 3414 (US 524, CA 31, ROW 2859)
Official record key
device-enforcement:Z-0816-2014

Official wording

Reason: RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.

Code information: Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.