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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00945-1
Product Name/Description cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD).

Affected part: ADP Nozzle

Material Number: 07563116001

ARTG Number: 212706
(Roche Diagnostics Australia Pty Limited - Instrument/analyser IVDs)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 9/07/2018
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue During internal investigations, Roche Diagnostics confirmed that in rare cases, sample material may come in contact with the pipetting nozzle during operation of the cobas p 612 pre-analytical system. This may lead to contamination of samples and, if a highly sensitive analytical technology is used (e.g. molecular testing), inaccurate results may be produced.

cobas p 612 pre-analytical systems that use disposable filter tips are not affected by this issue.

Roche Diagnostics has received no complaints worldwide for this issue, including none from Australian customers to date.
Recall Action Product Defect Correction
Recall Action Instructions Roche Diagnostics Australia is advising that the use of disposable filter tips in the cobas p 612 pre-analytical system will be mandatory until the root cause is identified and appropriate corrective actions have been implemented.

UPDATE 07/03/2019:
Roche Diagnostics has developed an updated IFU describing the use of new non-conductive filter tips for the cobas p 612 pre-analytical system. This IFU update will be provided to all customers though an additional customer letter.

Roche Diagnostics will release new non-conductive filter tips for the cobas p 612 pre-analytical system, providing an alternative option to the ep Dualfilter T.I.P.S.
The new Roche non-conductive filter tips and the ep Dualfilter T.I.P.S can be used interchangeably without any hardware, software or configuration changes on the cobas p 612 pre-analytical system.
Contact Information 02 9860 2357 - Roche Diagnostics