FDA-Device2012-11-14Class II
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
Sendx Medical Inc
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.
Sold states
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.
Affected count
767 units
Manufactured in
1945 Palomar Oaks Way, N/A, Carlsbad, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0195-2013Don't want to check this manually?
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