Recall Monitor
Health Products

Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue
Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol AssayMore than 10 numbers, contact manufacturer.OSR6196
Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol AssayMore than 10 numbers, contact manufacturer.OSR6296

Issue

LDL cholesterol OSR6x96 does not meet the triglyceride interference claim per the BAOSR6x96 v10 IFU which states "no significant interference up to 1,500 mg/dl triglyceride" where the criteria for no significant interference is recovery within 10% of the initial value as outlined in the IFU.

Get told about the next health product recall.
Get health product recall alerts

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