The st aia-pack tsh analyte application manual states the following: limitations of the procedure for diagnostic purposes, the results obtained from this assay should be used in conjunction with other data (e.G., symptoms, results of other tests, clinical impressions, therapy, etc.).Using st aia-pack tsh, the highest concentration of thyroid stimulating hormone measurable without dilution is approximately 100 [?]iu/ml, and the lowest measurable concentration is 0.03 [?]iu/ml (assay sensitivity).Although the approximate value of the highest calibrator is 100 [?]iu/ml, the exact concentration may be slightly different.The assay specification, assay range high, should be defined as the upper limit of the assay range, 100 [?]iu/ml.Although hemolysis has an insignificant effect on the assay, hemolyzed samples may indicate mistreatment of a specimen prior to assay and results should be interpreted with caution.Lipemia has an insignificant effect on the assay except in the case of gross lipemia where spatial interference may occur.Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (hama).Such specimens may show falsely elevated values when tested for thyroid stimulating hormone.Certain medications may interfere with assay performance.Specimens from patients taking medicines and/or medical treatment may show erroneous results.All results should be interpreted with respect to the clinical picture of the patient.For a more complete understanding of the limitations of this procedure, please refer to the specimen collection and handling, warnings and precautions, storage and stability, and procedural notes sections in this insert sheet.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 30aug2019 through aware date 30sep2020.There were no similar complaints identified during the searched period.The probable cause of the reported event was interfering substance of unknown origin.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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