Radiometer America Inc: Medical Device Recall in 2014 - (Recall #: Z-0816-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 15, 2013

Date Posted: January 29, 2014

Recall Number: Z-0816-2014

Event ID: 66875

Reason for Recall:

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

Status: Terminated

Product Quantity: Total 3414 (US 524, CA 31, ROW 2859)

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.

Voluntary or Mandated:

Voluntary: Firm initiated