| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00418-1 |
| Product Name/Description |
DxI 9000 Access Immunoassay Analyser. An in vitro diagnostic medical device (IVD)
Software: 1.17.0 and below
REF: C11137
Multiple assays and reagent part numbers
ARTG 177999
(Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
If a sample test result relative light units (RLUs) are between the RLU value of the calibration curve math model parameter A and the S0 calibrator level mean RLUs, then the DxI 9000 Access Immunoassay Analyser will report No Result rather than 0.
There may be a delay in reporting test results which could lead to a delay in patient treatment.
This issue affects approximately 0.04% of Access assay patient sample test results. The Access Sensitive Estradiol assay has the highest rate of occurrence (approximately 2.2%). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
If No Result is observed for a patient test, the operator should:
• Rerun the sample test on either the same or a different analyser.
• Recalibrate the assay.
• Repeat the sample test on a different immunoassay platform if one is available.
Beckman Coulter has identified the root cause of this problem and will implement the correction with a future software release.
A Beckman Coulter service representative will contact customers to schedule the system software upgrade as soon as it becomes available. |
| Contact Information |
1800 060 881 - Customer Support Centre |