Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Test
Brand(s)
Last updated
Summary
Product
Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Test
Issue
Medical devices - Labelling and packaging
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
Affected products | Lot or serial number | Model or catalog number |
---|---|---|
Cholestech Ldx Total Cholesterol Test | All lots. | 10-987 10-991 10-990 10-989 |
Cholestech Ldx Hdl Cholesterol Test | All lots. | 10-987 10-991 10-990 10-989 |
Cholestech Ldx Triglycerides Test | All lots. | 10-991 10-989 |
Cholestech Ldx Glucose Test | All lots. | 10-991 10-990 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Alere San Diego, Inc.
9975 Summers Ridge Road, San Diego, California, United States, 92121
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64285