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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00926-1
Product Name/Description COBAS INTEGRA 800 Software Version 9864.C2. An in vitro diagnostic medical device (IVD).
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 4/09/2013
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue A software bug has been detected in the COBAS INTEGRA 800 Software version 9864.C2 which affects the execution of routine maintenance of the ISE module. The issue is caused by the ISE counters in the software being reset to zero whenever the ISE rack is removed from the analyser. lf ISE Service Actions and manual maintenance items are not executed at their recommended intervals, there is a potential risk of increased occurrence of calibration flags (Slope, SOL I DEV etc), as well as incorrect and unflagged ISE results.
Recall Action Recall for Product Correction
Recall Action Instructions Roche is currently working on a software fix expected to be implemented by the end of the year. Until the software is available, Roche recommends that operators manually track all ISE counters and to manually request the corresponding Service Action in the Service Software.
Contact Information 1800 645 619 - Roche Diagnostics National Support Centre