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Beckman coulter access erythropoetin reagent

Official notice

9 Apr 2025

Last checked

9 Apr 2025

Medium riskHealth Canada
Watch Beckman Coulter

An official Health Canada notice concerns Beckman coulter access erythropoetin reagent. 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 Published 2025-04-09.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77250

Official notice

2025-04-09

The hazard

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

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

exhibits

Recall Numbers

77250

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Affected products

Product 1

Affected products - Unicel DxI 600 Access Immunoassay System - EPO (Erythropoietin) Assay, Lot or serial number - 439363, Model or catalogue number - A16364

Product 2

Affected products - Unicel DxI 800 Access Immunoassay System - EPO (Erythropoietin) Assay, Lot or serial number - 439363, Model or catalogue number - A16364

Product 3

Affected products - Access System - EPO (Erythropoietin) Assay, Lot or serial number - 439363, Model or catalogue number - A16364

Product 4

Affected products - Access EPO, Lot or serial number - 439363, Model or catalogue number - A16364

Risk / hazard

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

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 Access Erythropoetin Reagent

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter, Beckman Coulter Access Erythropoetin Reagent.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77250

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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