Health Products

Beckman Coulter Au Immunochemistry System - Apolipoprotein B

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Beckman Coulter Au Immunochemistry System - Apolipoprotein B
Issue: Medical devices - Labelling and packaging
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 catalog number
Beckman Coulter Au Immunochemistry System - Apolipoprotein B2631OSR6143
Beckman Coulter Au2700 Immunochemistry System - Apolipoprotein B2631OSR6143
Beckman Coulter Au5400 Immunochemistry System- Apolipoprotein B Assay2631OSR6143

Issue

The Apo B lot 2631 VAS LOSR6143_2631_ML.01 contains an incorrect target value of 166 mg/dl for the level 4 calibrator ODR3022, lot 3000. The correct level 4 target value is 116 mg/dl. The value in g/l unit is correct. Recall Start Date: April 21, 2025

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