Beckman Coulter Thyroglobulin Assay
Brand(s)
Last updated
Summary
Product
Beckman Coulter 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 | Model or catalogue number |
|---|---|---|
| Unicel Dxi 600 Access Immunoassay System - Thyroglobulin Assay | 234355 233806 234171 234443 234444 234617 337940 | 33865 |
| Access System - Thyroglobulin Assay | 234355 233806 234171 234443 234444 234617 337940 | 33865 |
| Unicel Dxi 800 Access Immunoassay System - Thyroglobulin Assay | 234355 233806 234171 234443 234444 234617 337940 | 33865 |
Issue
In April 2023 Beckman Coulter distributed a letter that provided alternate access thyroglobulin calibrator cards for use with the thyg reagent packs.It has been determined through an internal investigation that when used the calibrator card will cause a decrease of approximately 11% in patient results.
Recall start date: July 3, 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-73965
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