Health product recall

Beckman Coulter Thyroglobulin Assay

Last updated

Summary

Product
Beckman Coulter Thyroglobulin Assay
Issue
Medical devices - Performance issue
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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