Beckman Coulter Access Erythropoetin Reagent
Brand(s)
Last updated
Summary
Product
Beckman Coulter Access Erythropoetin Reagent
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Unicel DxI 600 Access Immunoassay System - EPO (Erythropoietin) Assay |
439363 |
A16364 |
Unicel DxI 800 Access Immunoassay System - EPO (Erythropoietin) Assay |
439363 |
A16364 |
Access System - EPO (Erythropoietin) Assay |
439363 |
A16364 |
Access EPO |
439363 |
A16364 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Health products - Medical devices - Haematology
Companies
| Beckman Coulter, Inc. |
| 250 S. Kraemer Blvd., Brea, California, United States, 92821 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77250
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