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Beckman coulter au immunochemistry system- immunoglobulin m (igm)
Official notice
7 Jun 2024
Last checked
7 Jun 2024
An official Health Canada notice concerns Beckman coulter au immunochemistry system- immunoglobulin m (igm). 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 Published 2024-06-07.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75639
Official notice
2024-06-07
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
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The source does not list specific retailers. See the official notice for where affected products were sold.
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Brand: Beckman Coulter, Beckman Coulter Au Immunochemistry System- Immunoglobulin M.
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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