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Type of Product Medical Device
TGA Recall Reference RC-2024-RN-00420-1
Product Name/Description DxI 9000 Access Immunoassay Analysers. An in vitro diagnostic medical device (IVD).

Software: SW 1.17.0 and below

REF: C11137

Product Identifier: (01)15099590230623(17)240229(11)220301

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 Beckman Coulter Australia Pty Ltd
Reason/Issue Routine patient sample processing may be delayed and result in sample wheel timeout (SWT) flags. This issue does not affect STAT sample processing.

The delay occurs when:
1. Quality control (QC) material is configured
2. An automatic QC order is placed for an assay assigned to a specific onboard reagent pack
3. A rack with QC material is placed on board
4. The onboard reagent pack assigned to the QC order is depleted or the reagent pack is expired
5. Routine patient tests are ordered and placed on board
6. Routine priority tests do not run until the SWT flag is applied to the QC samples
7. The routine priority tests that did not start after 3 hours onboard will time out with a SWT flag

As a result, there may be a delay in reporting test results which could lead to a delay in patient treatment.

The issue does not impact Access hsTnI, Access NT-pro BNP, or Access Intact PTH Intraoperative Mode patient test results due to the Assay Protocol File High test priority.
Recall Action Product Defect Correction
Recall Action Instructions Customers are to action the following instructions:

•If a SWT flag is observed for a patient sample test result, rerun the sample test.

•Cancel automatic QC test orders prior to loading the QC material and reorder manually.

•Refer to the Running QC Tests topic in the System Help or IFU for more information.

A Beckman Coulter service representative will contact affected customers to schedule the system software upgrade as soon as it becomes available.
Contact Information 1800 060 881 - Customer Support Centre