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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