Public recall detail

Beckman Coulter Au Immunochemistry System - Apolipoprotein B

2025-05-07

medium
Recall Safety notice
Quick summary

Quick summary: Beckman Coulter Au Immunochemistry System - Apolipoprotein B. Date: 2025-05-07.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Beckman Coulter Au Immunochemistry System - Apolipoprotein B. Date: 2025-05-07.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBECKMAN COULTER, INC.
ProductBeckman Coulter Au Immunochemistry System - Apolipoprotein B
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-77411

Affected products

ProductBeckman Coulter Au Immunochemistry System - Apolipoprotein B
Lot2631
ModelOSR6143
Serial number2631
DescriptionBeckman Coulter Au Immunochemistry System - Apolipoprotein B
ProductBeckman Coulter Au2700 Immunochemistry System - Apolipoprotein B
Lot2631
ModelOSR6143
Serial number2631
DescriptionBeckman Coulter Au2700 Immunochemistry System - Apolipoprotein B
ProductBeckman Coulter Au5400 Immunochemistry System- Apolipoprotein B Assay
Lot2631
ModelOSR6143
Serial number2631
DescriptionBeckman Coulter Au5400 Immunochemistry System- Apolipoprotein B Assay

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77411
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2025-05-07

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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