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Health Canada Medical devices

Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Test

Issued June 20, 2022
Issue
Alere San Diego has identified that bilirubin interference level listed in the package insert is incorrect. Concentrations less than 5.0 mg/dl can impact the accuracy of triglyceride (TRG) and High-density lipoproteins (HDL). Bilirubin levels of 2.0 mg/dl (conjugated) or 1.6 mg/dl(unconjugated) were found to be the correct concentrations. this change impacts all lots produced since product launch. Recall start date: June 13, 2022
Hazard description
Labelling and packaging - Performance
Product
Product name
Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Test
Reference
ID
RA-64285