Mdr 1218996-2017-00040 addendum: magellan's investigations have confirmed that extended incubation (ie overnight) of blood/treatment reagent mixtures at room temperature or incubation at high temperatures (ie, 60 c) improved test results for some blood specimens.Studies suggest the venous blood collection tube contributes to the low results as similar low results are not observed with capillary blood samples.Magellan has since determined the root cause of suppressed results with venous bloods samples to be directly related to a material change in the rubber stopper of the bd blood collection tube kit.Current labeling indicates that venous samples should not be used on the leadcare system.Same device kit from customer could not be used.The lot 1404au materials were from magellan inventory.Case number; (b)(4).Late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on 29jun2017.Testing was all done on (b)(6) 2014 and patient sample results for lcu vs icp-ms (in ug/dl) were all filled under one mdr.We will now be submitting separate mdrs for each individual patient result.Results: (lcu vs icp-ms).4.3 vs 6.4 [1218996-2019-00055]; 4.6 vs 7.3 [1218996-2019-00056]; 2.1 vs 5.4 [1218996-2019-00057]; 3.5 vs 7.8; 1.8 vs 5.1 [1218996-2019-00059]; 3.9 vs 6.5 [1218996-2019-00060].
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