| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00594-1 |
| Product Name/Description |
DxI 9000 Access Immunoassay Analyzer. An in vitro diagnostic medical device (IVD)
Reference number: C11137
Serial numbers: 300116 – 300156
ARTG 177999
(Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
The DxI 9000 Access Immunoassay Analyzer reagent storage module circuit board ground screw may cause an unintentional electrical connection during startup.
This electrical connection may overheat and damage the circuit board. If the circuit board overheats, a small amount of smoke may be emitted.
If the circuit board is damaged, condensation may form in a window the DxI 9000 analyzer uses when scanning the Access assay reagent pack barcode.
Condensation in this window may prevent the DxI 9000 analyzer from loading additional reagent packs, and an RSM Barcode Read Failure error will occur.
This problem may delay reporting patient test results to the physician, which might impact treatment. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
•Contact a Beckman Coulter service representative if the laboratory observes any RSM Barcode Read Failure error messages, or notices smoke or a burning smell emerging from the DxI 9000 analyzer.
•No action is necessary if the laboratory has not observed any RSM Barcode Read Failure error messages.
Beckman Coulter service representative will contact customers to schedule a part replacement that resolves this problem.
Beckman Coulter will no longer ship DxI 9000 Access Immunoassay Analyzers with the affected ground screw. |
| Contact Information |
1800 060 881 - Customer Support Centre |