Recall Monitor
Health Products

Beckman Coulter Access Erythropoetin Reagent

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry, Health products - Medical devices - Haematology
Product: Beckman Coulter Access Erythropoetin Reagent
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Unicel DxI 600 Access Immunoassay System - EPO (Erythropoietin) Assay439363A16364
Unicel DxI 800 Access Immunoassay System - EPO (Erythropoietin) Assay439363A16364
Access System - EPO (Erythropoietin) Assay439363A16364
Access EPO439363A16364

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

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