| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01110-1 |
| Product Name/Description |
DxI 9000 Access Immunoassay Analyser. An in vitro diagnostic medical device (IVD)
REF Number: 33410, C11137
ARTG 213978
(Beckman Coulter Australia Pty Ltd - Clinical chemistry autoimmune IVDs)
ARTG 177999
(Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter advise:
Issue 1: The DxI 9000 Access Immunoassay Analyser assay protocol file for the Access Ultrasensitive Insulin assay applies an incorrect conversion factor when converting from system default units of µIU/mL to the International System of Units (SI units) of pmol/L.
Issue 2: The DxI 9000 Analyser incorrectly displays the quantitative threshold of the lowest reportable result when there is a unit change performed within the test configuration and the test is ran producing results under the lowest reportable result.
Issue 3: The system incorrectly reports a result of "0" when a user-created expression includes non-numerical symbols (e.g., ">" or "<") for calculated tests. This may lead to erroneously low reporting a result of "0" to the physician.
Issue 4: The analyser may not aliquot a reserve volume for assays configured to do so if the assay LIS code is different to the assay Test ID |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should read the customer letter carefully and noted all the required mitigations for each of the 4 issues.
For Issue 1: Beckman Coulter will release an updated Access Ultrasensitive Insulin APF on the DxI 9000 analyser that includes the correct conversion factor for SI units (pmol/L) and will have a representative contact customers when the updated APF is available.
For issues 2-4 Beckman Coulter 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 |