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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00607-1
Product Name/Description VITROS 5,1 FS System

Product Codes: 6801375 and 6801890

Unique Device Identifier Number: 10758750001132 and 10758750001644

ARTG Number: 180199
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/07/2015
Responsible Entity Ortho-Clinical Diagnostics
Reason/Issue Ortho Clinical has received two complaints:
1) When a customer installed the ADD that supported the new VITROS Chemistry Products HbA1c Reagent Kit, the VITROS 5,1 FS system posted the two condition codes UA7-239 and SYD-024. The condition codes occurred because the short assay name for the new VITROS assay had the same name as a User Defined Assay currently in use on their VITROS 5,1 FS System. As a result, the User Defined Assay target was deleted from their system.

2) When a customer installed the ADD, their system became unresponsive (screen freeze occurred) that required the VITROS 5,1 FS System to be restarted; the system posted condition code UZ0-047 after the restart was initiated.

Due to a software coding error, for both scenarios, ALL default settings were restored from the ADD instead of retaining the user modified (configured) parameters and the operator was not alerted by the system.
Recall Action Recall for Product Correction
Recall Action Instructions OCD has determined that the root cause of this anomaly is due to an error in the software code. The resolution is currently under development and will be available in a future version of software. In the interim, OCD has provided workaround instructions to assist end users mitigate this issue. This action has been closed-out on 15/08/2016.
Contact Information 1800 032 359 Customer Technical Services