Company:Sendx Medical Inc
Date of Enforcement Report:9.5/2007
Class:ll
PRODUCT
ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863, Recall # Z-1201-2007
REASON
The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation error.
RECALLING FIRM/MANUFACTURER
Sendx Medical Inc., Carlsbad, CA, by e-mail on June 6, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
165 CDs
DISTRIBUTION
Nationwide and Internationally
