Beckman Coulter Au Immunochemistry System- Immunoglobulin M (IgM)
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Beckman Coulter Au 2700 Immunochemistry System - Immunoglobulin M (IgM) |
All lots. |
OSR61173 |
Beckman Coulter Au 5400 Immunochemistry System - Immunoglobulin M (IgM) |
All lots. |
OSR61173 |
Beckman Coulter Au Immunochemistry System- Immunoglobulin M (IgM) |
All lots. |
OSR61173 |
Issue
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
Additional information
Details
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, California, United States, 92821
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