Cholestech Ldx Test recall in Canada: Inaccurate results
In plain language
This recall involves Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Tests sold in Canada. They are being recalled because the bilirubin interference level listed in the package insert is incorrect, which can impact the accuracy of triglyceride and HDL results. Healthcare professionals should contact the manufacturer for additional information.
What to do
- Contact the manufacturer if you require additional information.
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Affected products
Cholestech Ldx Total Cholesterol Test
Model: 10-987, 10-989, 10-990, 10-991
Lot: All lots
Cholestech Ldx Hdl Cholesterol Test
Model: 10-987, 10-989, 10-990, 10-991
Lot: All lots
Cholestech Ldx Triglycerides Test
Model: 10-989, 10-991
Lot: All lots
Cholestech Ldx Glucose Test
Model: 10-990, 10-991
Lot: All lots
Why this matters
Inaccurate test results
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 10-987, 10-989, 10-990, 10-991
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Inaccurate test results
What should consumers do?
Contact the manufacturer if you require additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Inaccurate test results
When was this product recalled?
This product was recalled on June 20, 2022.
Is the Alere San Diego, Inc. brand affected by this recall?
Yes, Alere San Diego, Inc. products are affected by this recall. This recall involves Cholestech Ldx Total, HDL, Triglycerides Cholesterol and Glucose Tests sold in Canada. They are being recalled because the bilirubin interference level listed in the package insert is incorrect, which can impact the accuracy of triglyceride and HDL results. Healthcare professionals should contact the manufacturer for additional information.