Official recall record
Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-12-10
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
LDL cholesterol OSR6x96 does not meet the triglyceride interference claim per the BAOSR6x96 v10 IFU which states "no significant interference up to 1,500 mg/dl triglyceride" where the criteria for no significant interference is recovery within 10% of the initial value as outlined in the IFU.
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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