Official recall record
DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-09-26
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Beckman Coulter has confirmed a software anomaly on the DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results (R1, R2) and potential delays in reporting (R3), risking erroneous diagnoses if undetected
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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