Official recall record
Access System - Total T4 Assay
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-02-15
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Beckman Coulter has determined that the affected Access Total T4 reagent lots demonstrate an assay imprecision that is higher than expected. An unusual amount of precipitate may be observed in the Access Total T4 reagent packs. Recall start date: February 5, 2024
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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