Official recall record
UniCel DxI 600 Access Immunoassay System-Total T4 Assay
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-03-19
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Access Total T4 calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. In the worst-case scenario, there is a medium safety risk associated with this issue due to the potential to cause false low patient results.
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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