Radiometer America Inc: Medical Device Recall in 2015 - (Recall #: Z-1046-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 8, 2014

Date Posted: February 11, 2015

Recall Number: Z-1046-2015

Event ID: 70103

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.

Status: Terminated

Product Quantity: 5002 units

Code Information:

Model number 393-090 (instrument). The affected analyzers are serial numbers 393-090R0027N001 to present.

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.

Voluntary or Mandated:

Voluntary: Firm initiated