Beckman Coulter Au 2700/5400 Immunochemistry System - Immunoglobulin A (IgA)
Brand(s)
Last updated
Summary
Product
Beckman Coulter Au 2700/5400 Immunochemistry System - Immunoglobulin A (IgA)
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 Au 5400 Immunochemistry System - Immunoglobulin A (IgA) |
All lots. |
OSR61171 |
Beckman Coulter Au2700 Immunochemistry System - Immunoglobulin A (IgA) |
All lots. |
OSR61171 |
Issue
Internal testing determined that IgA OSR61171 failed to meet the interference claim as stated per the IFU for the lipemic serum interference. All lots of IgA OSR61171 are affected.
Recall start date: July 17, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
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-74059
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