| TGA Action ID |
RC-2025-RN-00315-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
DxI 9000 Access Immunoassay Analyzer. An in vitro diagnostic medical device (IVD)
REF: C11137
SW Versions: SW 1.20.0 and below
ARTG 177999 |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
15099590732103 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
DxI 9000 analyzers that are run with the system software versions SW 1.20.0 and below and are connected to a host system (laboratory information system (LIS) or middleware may be affected by a communication problem.
If the device has accumulated cancelled QC test results that were not sent to the host system, the analyzer may lose communication with the host system and affects sample processing. The lost connection cannot be restored by routine troubleshooting.
The device responds in one of the following ways when it loses communication with the host system:
-An event message is generated
-No event message
Either response interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment. |
| Instructions for Customers/Users |
Each time that the Cleaning Routine maintenance procedure is due, Beckman Coulter recommends that customers perform the steps provided in the Customer Letter before performing the Cleaning Routine.
Beckman Coulter has provided instructions for troubleshooting both scenarios: when the analyzer loses communication with the host system and does not generate an event message, and when it does generate an event message.
To prevent delays in reporting patient results, samples can be run on a different analyzer.
A service representative will contact affected customers to schedule the software upgrade when it becomes available. |
| Action Commencement Date |
18/03/2025 |
| Responsible Entity |
|
| Contact Information |
02 9844 6000 - Beckman Coulter |