| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00436-1 |
| Product Name/Description |
Immunoglobulin M (IgM). An in vitro diagnostic medical device (IVD)
Reference number: OSR61173
Lot number: All
ARTG 213984
(Beckman Coulter Australia Pty Ltd - Clinical chemistry-specific protein IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/05/2024 |
| Responsible Entity |
|
| Reason/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.
Where LIH Influence Check settings are in use, levels of lipemia with turbidity levels = 200 mg/dL and = 500 mg/dL will not flag.
Patient samples with high levels of lipemia result in a false low result or cause a high result to report as normal.
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 Action |
Product Defect Correction |
| Recall Action Instructions |
- Customers are to determine if the LIH Influence Check is enabled for IgM.
- Customers are to update the LIH Influence Check settings for Lipemia on AU480, AU680, DxC 500 AU and DxC 700 AU analyzers if they are enabled for IgM following the steps outlined in the Customer Letter.
- Beckman Coulter recommends sharing the content of this letter with the laboratory and/or Medical Director to determine if a review of previous patient test results should be conducted.
- The IgM settings sheet for AU480, AU680, DxC 500 AU and DxC 700 AU (BASOSR6x173) and the DxC 500 AU will be updated by Beckman Coulter so that the Lipemic Influence Check is reduced from +++++ to +++. |
| Contact Information |
1800 060 881 - Customer Support Centre |