Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its cobas p 612 pre-analytical system (LCP1) [GMMI: 07563116001, SW Version: All versions from 2.0 and higher].
The manufacturer has confirmed that sample material may potentially come in contact with the pipetting nozzle during operation. The possible presence of biological material on the nozzle has the potential to cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology. However, no complaints of false positives have been received from users. Cobas p 612 (63x) (LCP1) systems that use disposable filter tips are not affected by a potential contamination as the filter tips create a physical barrier preventing liquid exposure to the nozzle.
According to the manufacturer, the current issue deals with the occasional deposition of sample material at the bottom of the sample nozzle and its possible carry over to other specimens. In the case of molecular tests, even trace amount of nucleic acids may be amplified to detectable concentration and cause false positive results (e.g. HIV RNA, HCV RNA, HBV, and DNA). This may lead to an incorrect diagnosis and inappropriate clinical management of the patient under examination.
The root cause investigation is still ongoing. Affected users using cobas p 612 pre-analytical systems (63x) for aliquoting in combination with non-filter tips must use filter tips until the root cause is identified and appropriate corrective actions have been implemented. Affected users are reminded to perform the daily preparation and weekly device care procedures described in the Operator's Manual.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 July 2018