Public recall detail

Beckman Coulter Access Erythropoetin Reagent

2025-04-09

medium
Recall Safety notice
Quick summary

Quick summary: Beckman Coulter Access Erythropoetin Reagent. Date: 2025-04-09.

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 Access Erythropoetin Reagent. Date: 2025-04-09.

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 Access Erythropoetin Reagent
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77250

Affected products

ProductUnicel DxI 600 Access Immunoassay System - EPO (Erythropoietin) Assay
Lot439363
ModelA16364
Serial number439363
DescriptionUnicel DxI 600 Access Immunoassay System - EPO (Erythropoietin) Assay
ProductUnicel DxI 800 Access Immunoassay System - EPO (Erythropoietin) Assay
Lot439363
ModelA16364
Serial number439363
DescriptionUnicel DxI 800 Access Immunoassay System - EPO (Erythropoietin) Assay
ProductAccess System - EPO (Erythropoietin) Assay
Lot439363
ModelA16364
Serial number439363
DescriptionAccess System - EPO (Erythropoietin) Assay
ProductAccess EPO
Lot439363
ModelA16364
Serial number439363
DescriptionAccess EPO

Issue

Beckman Coulter has determined that the affected access erythropoietin (EPO) reagent lot number exhibits an approximate concentration bias of ~-22% with patient samples when compared to alternate EPO reagent lots. Recall start date: February 3, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry Health products - Medical devices - Haematology
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-77250
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2025-04-09

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

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