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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
ABL80 FLEX CO-OX analyzer		see related information
Date Posted November 05, 2012
Recall Number Z-0195-2013
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
Code Information Serial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34.
Recalling Firm/
Manufacturer		 Sendx Medical Inc
1945 Palomar Oaks Way
Carlsbad, California 92011-1300
Reason for
Recall		 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.
Action SenDx Medical sent a recall letter to all their foreign customers on January 6, 2010, to informed them of the ABL80 FLEX CO-OX recall via the Radiometer Field Action Notification (FAN) system. The Field Action Notes informed the customers of the problem identified and the action to be taken. Customers were instructed to submit confirmation fax#1 to confirm that the customer letter has been distributed to all ABL80 CO-OX customers by January 31, 2010. Customers were instructed to submit confirmation fax #2 to confirm that all ABL80 CO-OX analyzers have been upgraded to version 1.35 by 6/30/10. In the U.S., the customer was provided with a software upgrade CD along with a letter advising them to the issues associated with the recall. Customers with questions were instructed to contact TechLine at (800) 736-0600 opt 2.
Quantity in Commerce 767 units
Distribution 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.
 
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