Health Canada — Medical Devices · Canada · 2019-08-09 · Type II
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Reported risk: Siemens Healthcare Diagnostics, Inc. is informing customers that the Atellica CH 930 Analyzer may report incorrect serum indices for Hemolysis (H) and Lipemia (L) when using the UN_c test as a donor method, and the Hemolysis Icterus Lipemia (HIL) function is enabled. Due to bubbles in the reaction cuvette, there is a potential for falsely depressed H results (e.g. H index of 3 or higher, reported as ¿1 ) at a rate of 0.3-1% and falsely elevated L results (e.g. L index of 0 reported as ¿ 1) at a rate of 2.9%. In all cases of falsely depressed H results, the L results will be elevated ¿1. For samples not using UN_c as the donor method the indices are not affected. THE DONOR METHOD THE INDICES ARE NOT AFFECTED.
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