Health product recall

Beckman Coulter Au Immunochemistry System - Apolipoprotein B

Last updated

Summary

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

Affected products

Affected products

Lot or serial number

Model or catalog number

Beckman Coulter Au Immunochemistry System - Apolipoprotein B

2631

OSR6143

Beckman Coulter Au2700 Immunochemistry System - Apolipoprotein B

2631

OSR6143

Beckman Coulter Au5400 Immunochemistry System- Apolipoprotein B Assay

2631

OSR6143

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Beckman Coulter, Inc.

250 S. Kraemer Blvd., Brea, California, United States, 92821

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77411

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