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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01115-1
Product Name/Description cobas 8000 core unit with software versions 5.01 and later. An in vitro diagnostic medical device (IVD)

Material Number: 05641446001

ARTG Number: 173887
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 28/08/2017
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue Due to a software limitation, in very rare cases, Roche has identified that the system configuration of the control unit software may be reset to its default settings.

For instruments which are connected to laboratory automation systems (CLAS) and/or are running in Barcode mode, if the issue has occurred and at the start of the next Operation:
-Barcodes are no longer read
-Rack loading from CLAS is no longer possible
-Additional settings may revert to default settings during operation

Roche has received 6 complaints globally to date; none from Australian customers. There is a risk of incorrect results, especially when “Alarm Settings” and “Analyzer Settings” unknowingly revert to “default” settings.
Recall Action Recall for Product Correction
Recall Action Instructions 1. If the software issue is detected, stop the instrument using the “Stop” button and contact the Roche Diagnostics Australia call centre on 1800 645 619, quoting the Roche reference number "CPS-2017-017".
2. After the system settings have been restored by Roche Diagnostics Australia personnel re-run any samples which were measured in the period between the issue occurring and the instrument being stopped.
3. Retain this letter until the software upgrade has been installed.
4. Acknowledge receipt of this communication via the link/email address in the supplied customer letter, even if no system which is subject to this recall is on-site, as this information is required to reconcile this process.

This action has been closed out on the 03/12/2018.
Contact Information 1800 645 619 - Roche Diagnostics Call Centre