Device Recall SenDx Medical Inc. ABL80FLEX

Model number: 393-839 Serial number(s): 304157, 304160 and 304162 to 305414 for ABL80 FLEX analyzers

Clinical Chemistry and Clinical Toxicology Devices

2

No

One US consignee in state of OH. Other consignees are international such as Australia, France, Netherlands, Denmark, China, United Kingdom, Turkey, Switzerland, Japan, India, Poland, Spain, and Germany. Distribution list submitted with supporting doc.s

SenDx Medical Inc || ABL80FLEX || Blood Gas, pH, Electrolyte, and Metabolite System || The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.