Siemens healthcare diagnostics, inc.Has confirmed that the atellica ch 930 module 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 less than or equal to 1 ) at a rate of 0.3-1% and falsely elevated 'l' results (e.G.L index of 0 reported as more than or equal to 1) at a rate of 2.9%.In all cases of falsely depressed h, l is elevated more than or equal to1.For samples not using un_c as the donor method the indices are not impacted.An urgent medical device correction (umdc) asi19-02.A.Us was sent to us customers and an urgent field safety notice (ufsn) asi19-02.A.Ous was sent to ous customers in (b)(6) 2019.The umdc and ufsn advise customers who have multiple atellica ch 930 analyzers to generate un_c results on a different analyzer than the hil tests.For customers who have only one atellica ch 930 analyzer when un_c is part of the test order and alt and ast are not, hil tests should be ordered separately, or alternatively hil ordering can be turned off.
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