Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay

Recall Summary The Unicel Dxi 600 Access Immunoassay System's Thyroglobulin Assay has been recalled in Canada due to performance issues with the test. This assay is used to measure thyroglobulin levels, typically in thyroid cancer patients. The recall affects all users of this system across Canada.

Product
Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-07-23
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/f0a2bb04-f346-486b-a55b-0864b7bfeb58