The investigation determined that lower and higher than expected vitros creatinine (crea) results were obtained using vitros crea slides in combination with a vitros 5600 integrated system.The customer considered the non-vitros (labtest) results to be the expected crea results.The assignable cause of the event was not determined.There were no details provided regarding the patient diagnosis, medication list, or other assay results.Other than the data provided by the ortho laboratory specialist, there has been no additional investigation of the samples, reagent or analyzer.Therefore, a vitros crea slide lot issue, an instrument issue or a sample related issue cannot be ruled out as potential contributors to this event.Ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros crea lot 1522-3589-7685.
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