Product Wiki · Recalls · Health Canada — Medical Devices

Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay — recall 77759

Health Canada — Medical Devices · Canada · 2025-07-23 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
77759
Date of alert
2025-07-23
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-access-immunoas

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