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Beckman coulter au immunochemistry system - apolipoprotein b

Official notice

7 May 2025

Last checked

7 May 2025

Medium riskHealth Canada
Watch Beckman Coulter

An official Health Canada notice concerns Beckman coulter au immunochemistry system - apolipoprotein b. 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 Published 2025-05-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77411

Official notice

2025-05-07

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Lots

2631

Recall Numbers

77411

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Affected products

Product 1

Affected products - Beckman Coulter Au Immunochemistry System - Apolipoprotein B, Lot or serial number - 2631, Model or catalog number - OSR6143

Product 2

Affected products - Beckman Coulter Au2700 Immunochemistry System - Apolipoprotein B, Lot or serial number - 2631, Model or catalog number - OSR6143

Product 3

Affected products - Beckman Coulter Au5400 Immunochemistry System- Apolipoprotein B Assay, Lot or serial number - 2631, Model or catalog number - OSR6143

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Beckman Coulter, Beckman Coulter Au Immunochemistry System - Apolipoprotein B

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter, Beckman Coulter Au Immunochemistry System - Apolipoprotein B.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77411

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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