Health product recall

Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Test

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: 2022-06-23
Alert / recall type
Health product recall
Category
Health product - Medical device - 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