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Beckman Coulter Au Immunochemistry System- Immunoglobulin M (IgM) — recall 75639

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

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Agency
Health Canada — Medical Devices
Recall identifier
75639
Date of alert
2024-06-07
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/beckman-coulter-au-immunochemi

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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