Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Test
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Cholestech Ldx Total Cholesterol Test |
All lots. |
10-987 |
Cholestech Ldx Hdl Cholesterol Test |
All lots. |
10-987 |
Cholestech Ldx Triglycerides Test |
All lots. |
10-991 |
Cholestech Ldx Glucose Test |
All lots. |
10-991 |
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
Additional information
Details
Alere San Diego, Inc.
9975 Summers Ridge Road, San Diego, California, United States, 92121