Home / Recalls / Medical Devices
Sendx Medical Inc recalls ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable,
Recalled November 14, 2012 · FDA recall Z-0195-2013 · Sendx Medical
Hazard
The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters. · FDA Class II
Units
767 units
Sold at
Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic.
Description
The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
Product
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX 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
Manufacturer(s)
Sendx Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →