Corrective Action for Cholestech LDX Multi-Analyte Controls, Lipid Controls, and Calibration Verification Material, Alere San Diego Inc. / MDSS
2010.11.04
Product group In-vitro diagnostics
Reference 03678/10
Corrective Action of Alere San Diego Inc. / MDSS for Cholestech LDX Multi-Analyte Controls, Lipid Controls, and Calibration Verification Material because a reassignment of the ranges for HDL cholesterol in these materials is necessary. The customers were informed about the problem and how to avoid it.