| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00175-1 |
| Product Name/Description |
DxI 9000 Access Immunoassay Analyser. An in vitro diagnostic medical device (IVD)
Multiple serial numbers
Product Code/Catalogue Number: C11137
Software: 1.16.2 and below
ARTG 177999
(Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
In the DxI 9000 Access Analyzer Instructions for Use (IFU section “System Configuration”) the operator may configure a sample and select a reporting unit. If the user fails to follow the Instructions for Use (IFU) and does not select a unit of measurement (e.g., the field is left blank), the analyser will report the results as 0 mmol/L.
For example, if plasma is selected for the Access TSH assay and the unit field is left blank, the analyser will report the TSH results as 0 mmol/L. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should:
• Always configure tests as instructed in the DxI 9000 Access Analyser Instructions for Use (IFU).
• Confirm and review the appropriate units of measure were selected if new sample types have been configured.
• If a unit of measure was left blank:
o Select the appropriate unit of measure for the sample type.
o Perform a retrospective review of applicable test results.
• Repeat any tests as necessary.
Beckman Coulter has identified the root cause of this issue and will implement a correction with a future software release. A Beckman Coulter service representative will contact customers to schedule the software upgrade when it is available. |
| Contact Information |
1800 060 881 - Customer Support Centre |