Thereby, the analytical data reflect the results of patient samples and provide an objective assessment of the entire analytical system. Of course, nor does the manufacturing of our QC materials involve collaborations with any instrument, reagent or calibrator manufacturer.
With the “black box system” that most instrument producers offer nowadays, the best way medical laboratories can control their laboratory system is through the use of third party quality controls. ISO 15189 “Medical laboratories – Requirements for quality and competence” clearly states its recommendations with regards to the selection of QC materials: “.. Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”.
For lot specific documentation enter the 8-digit number included in your user manual
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