Events

Alerte De Sécurité sur cobas p 612 pre-analytical system (LCP1)

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Roche Diagnostics.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2018-07-06
  • Date de publication de l'événement
    2018-07-06
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180706.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Diagnostics, cobas p 612 pre-analytical system (LCP1)
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics