The investigation determined that a non-reproducible, higher than expected vitros amon patient sample result on a vitros 350 chemistry system.The assignable cause was most likely pre-analytical sample handling and storage, as the sample was stored frozen for more than 24 hours before testing.Patient sample stability, as per vitros amon instructions for use recommends patient samples frozen storage equal to or less than 24 hours prior to testing.Results of the within run precision testing were acceptable indicating acceptable instrument performance at the time the precision testing was performed.The assignable cause of this event is most likely due to improper pre-analytical sample handling and storage.
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