The investigation concluded that higher than expected ammonia results were obtained from samples from two different patients using vitros chemistry products amon slides lot 1018-0252-2336 on a vitros 5600 integrated system.The investigation was unable to determine a definitive assignable cause for this event.However, a sample related issue related to the affected patients or a transient issue affecting the vitros amon slides in use at the time of the event cannot be ruled out.The issue is isolated only to samples drawn from the affected patients in question, as other patient samples run over this time frame did not demonstrate a similar issue.Historical quality control results exhibited some within-laboratory imprecision, but not to the magnitude observed with the affected samples.In addition, a vitros amon within-run precision test had results within acceptable guidelines indicating vitros amon reagent lot 1018-0252-2336 was performing as intended on the vitros 5600 integrated system.Continual tracking and trending of complaint data does not indicate a potential systemic issue with vitros amon lot 1018-0252-2336.
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