Official recall record
Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-07-23
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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