Health Canada — Medical Devices · Canada · 2018-08-02 · Type I
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Reported risk: ARCHITECT EBV VCA IgM Reagent lots 85278LI00 and 85279LI00 show reduced RLU signals with 4 distributed ARCHITECT EBV VCA IgM Calibrator lots (71146LI00, 73014LI00, 79576LI00 or 83327LI00), leading to decreased cut-off RLU values in assay calibration. The decreased cut-off RLU values of maximum 20% will result into Quality Control S/CO values shifting up false grayzone patient results in the range of 0.50-0.60 S/CO false reactive patient results in the range 1.00-1.20 S/CO Cause investigation discovered that the reduced signals are driven by the microparticle component of the reagent, specifically by one lot of microparticle concentrate. Estimated Date of completion: October 2018. ARCHITECT EBV VCA IgM reagent lots 85278LI00 and 85279LI00 have been placed on Quality Hold on 20-Apr-2018 (QH1019-2018).
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