| 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 |
|
| 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.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9860 2357 - Roche Diagnostics |