Beckman Coulter Au Immunochemistry System - Apolipoprotein B
Brand(s)
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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