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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01299-1
Product Name/Description	cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software). An in vitro diagnostic medical device (IVD) ARTG Number: 174914
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/12/2012
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	There is a potential issue regarding the Date of Birth demographic in IT 1000 when a change in timezone is made on the IT 1000 server. If the user enters a patient date of birth manually in "Results & Results>Single Patient Edit", the cobas IT 1000 application may save an earlier date instead, the most common example being that the date of birth is listed as the day prior. For example; a patient date of birth is entered as 01-Nov-1931 and is saved as 31-Oct-1931.
Recall Action	Recall for Product Correction
Recall Action Instructions	Roche is providing work around instructions for users to implement.
Contact Information	1800 645 619 - Roche National Support Centre