Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)
Brand(s)
Last updated
Summary
Product
Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)
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 Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC) | All lots. | OSR61205 |
Issue
UIBC OSR61205 is not meeting interference claims for haemoglobin interference serum application. As per product ifus the claim is less than 10% up to 2g/l haemoglobin. While the high pool is meeting the claim, the low pool is failing the hemolysate interference specifications with results of -43.63% or -8.95 μmol/l.
Recall start date: July 1, 2025
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-77710
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