Events

Safety Alert for cobas p 612 pre-analytical system (LCP1)

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Roche Diagnostics.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2018-07-06
  • Event Date Posted
    2018-07-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180706.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: roche diagnostics cobas p 612 pre-analytical system (lcp1) 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.

Device

cobas p 612 pre-analytical system (LCP1)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche Diagnostics, cobas p 612 pre-analytical system (LCP1)
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics