Beckman Coulter Au2700/5400 Immunochemistry System - Transferrin Assay
Brand(s)
Last updated
Summary
Product
Beckman Coulter Au2700/5400 Immunochemistry System - Transferrin Assay
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 catalog number |
|---|---|---|
| Beckman Coulter Au2700 Immunochemistry System - Transferrin Assay | 2573 | OSR6152 |
| Beckman Coulter Au Immunochemistry System - Transferrin Assay | 2573 | OSR6152 |
| Beckman Coulter Au5400 Immunochemistry System - Transferrin Assay | 2573 | OSR6152 |
Issue
It has been determined that transferrin ref OSR6152 lot 2573 does not meet the reagent stability claim stated in the Instructions For Use (IFU). Customers may experience reagent blank shifts, calibration failures, and/or QC failures.
Recall start date: September 4, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Health products - Medical devices - Immunology
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-74301
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