Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay
Brand(s)
Last updated
Summary
Product
Unicel Dxi 600 Access Immunoassay System- Thyroglobulin 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 | Mode or catalogue number |
|---|---|---|
| Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay | 439163 | 33860 |
Issue
Multiple customers reported receiving high patient results when using access thyroglobulin reagent pack lot 439163. An internal review of batch records determined this was the first lot released using antibodies produced by BEC instead of a third party supplier.
Recall start date: July 2, 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-77759
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