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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00833-1
Product Name/Description	cobas 6800 system - cobas MPX, 96 tests and cobas MPX, 480 tests. An in-vitro diagnostic medical device (IVD). cobas MPX, 96 tests Material Number: 06997708190 All Lot Numbers affected cobas MPX, 480 tests Material Number: 06997716190 All Lot Numbers affected ARTG Number: 275469
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	27/06/2016
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	Roche Diagnostics Australia is informing users that in extremely rare cases, sample under-aspiration may occur when using the cobas 6800 system with sample input volumes of less than 450 µL. This issue will only affect the cobas MPX test when used with cadaveric donors, since the minimum sample volume required for cadaveric donors is 300 µL (for living donors, the minimum sample volume required is 1,000 µL). If bubbles or foam are present in the sample tube, this may lead to false sample liquid level detection and under-aspiration of the sample. This could potentially cause false negative / under-quantitated results that are not flagged.
Recall Action	Recall for Product Correction
Recall Action Instructions	Roche is advising users to ensure good sample preparation technique to avoid the formation of foam, clots, or bubbles in all samples, as described within the instrument safety manual. A look-back at previous cadaveric results is also recommended. Roche will be implementing a software correction as a permanent fix.. This action has been closed-out on 22/03/2018.
Contact Information	02 9860 2313 - Roche Diagnostics