Official recall record

Beckman Coulter Au Immunochemistry System- Immunoglobulin M (IgM)

Health Canada — Medical Devices · 2024-06-07 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2024-06-07
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

Beckman Coulter has determined that the LIH influence check for IgM lipemic interference on the AU480, AU680, DxC 500 AU and DxC 700 AU analyzers incorrectly states "+++++", which is equivalent to >500 mg/dL of intralipid. The correct LIH influence check for IgM lipemic interference for the AU480, AU680, DxC 500 AU and DxC 700 AU analyzers is "+++", which is equivalent to 200-299 mg/dL of intralipid. The LIH influence check for IgM lipemia interference for the AU5800 is not affected. The lipemia interference specification in the IgM Instructions For Use (IFU), BLOSR6X173 and BLOSR6X173EU is also not affected. Recall Start Date: May 27, 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.

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