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Health Canada Medical devices

Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay

Issued July 23, 2025
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
Hazard description
Performance
Product
Product name
Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay
Reference
ID
RA-77759