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