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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00783-3
Product Name/Description Cobas 8000 'v2' instrument drivers for Cobas IT 3000 (Used with Cobas IT 3000 versions 2.03.08 to 2.04.00); An in vitro diagnostic medical device (IVD)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/08/2012
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue There is a potential for incorrect handling of extra-long result messages that are sent form the cobas® 8000 Data Manager and received into IT 3000 using a “v2” instrument driver. This is applicable for messages that are greater than 33 results in length per episode and if the configuration of the predefined buffer size is not optimal.

The “v2” instrument drivers for cobas® 8000 use a buffer to ensure that extra-long result messages are processed correctly. If this buffer is not configured for the specific driver that is installed, then there can be a mismatch in the amount of data that is truncated. The effect of this being that results and flags after result #33 in the string may be delayed and in some cases may not be reported to cobas® IT 3000.
Recall Action Recall for Product Correction
Recall Action Instructions Roche are providing work around instructions until a software upgrade can be implemented to permanently fix the issue.
Contact Information 02 9860 2222 - Roche Diagnostics