The assignable cause of the unexpected results is unknown.The k+ results are discordant when comparing results obtained from a plain serum tube versus results from a sst.It is not anticipated that k+ results obtained from a plain serum tube and an sst would be different as they are both serum samples obtained during the same collection event.As the results are reproducible within each sample tube, pre-analytical sample mix-up could not be ruled out as a potential contributor.The customer was not following the collection device guidelines for sample preparation, therefore pre-analytical sample handling could not be ruled out as a contributor to the unexpected results.It was possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.The customer processed a vitros k+ precision which was within ortho acceptable guidelines, indicating that vitros k+ lot 4102-1063-0602 in combination with the vitros xt 7600 was operating as expected and not a likely contributor to the event.Historical quality control for vitros k+ lot 4102-1063-0602 was as expected, indicating that an issue with the reagent is not a likely contributor to the event.In addition, continual tracking and trending does not indicate a systemic issue with vitros k+ lot 4102-1063-0602.Email address for contact office is (b)(4).
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