The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid Profile Cassette/10-989; Cholestech LDX TC HDL Cassette/10-987

Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).

On 6/24/22, correction notices were mailed and emailed to customers who were asked to take the following actions: 1) Test results from patients with bilirubin levels above 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated) should be verified using another test method. 2) Complete and return the Customer Reply Form. 3) If you have forwarded the products listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 4) Retain this letter for your laboratory records. Customers with questions are encouraged to contact Technical Service at 877-308-8289.