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Cholestech ldx total, hdl, triglycerides cholesterol and glucose test
Official notice
20 Jun 2022
Last checked
20 Jun 2022
An official Health Canada notice concerns Cholestech ldx total, hdl, triglycerides cholesterol and glucose test. 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 Published 2022-06-20.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64285
Official notice
2022-06-20
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
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Brand: Alere San Diego, Cholestech Ldx Total Hdl Triglycerides Cholesterol And Glucose Test.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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