The customer received a questionable low elecsys free psa immunoassay result for one patient sample.The initial result was 0.014 ng/ml and the repeat result was 0.278 ng/ml.The sample was repeated on another analyzer and the result was 0.395 ng/ml.It was unknown if the erroneous result was reported outside of the laboratory.Clarification was requested but was not provided.There was no allegation of an adverse event.The reagent lot number and expiration date were requested but were not provided.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Based on the provided information, a general reagent issue was excluded.
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