Events

Avis De Sécurité sur K-Tips

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Roche Diagnostics GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2009-11-05
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/k-tips---important-safety-information-from-roche-diagnostics-gmbh&id=12d1f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
  • Notes supplémentaires dans les données
    3rd Party Publications
  • Cause
    Background information or related documents: roche has confirmed a problem with k-tips (m/n: 03287343001), lots 09001108, 09002108, 09003108, 09004108, 09005108, 09006108, 09007108, 09008108 and 09009108, which are for use with the cobas® ampliprep instrument. the affected lots contain k-tips that are completely closed (near the pipetting end of the k-tip), which prevents the cobas® ampliprep instrument from pipetting eluate from the spu into the k-tube. roche has confirmed that use of these defective k-tips will result in an invalid run and no reportable results. roche is recalling all affected lots. further information is available in the field safety notice below. important safety information - k tips note: field safety notices are placed on our website for information purposes. you will not normally need to take further action unless the manufacturer has contacted you directly or we have issued additional advice.

Device

K-Tips
  • Modèle / numéro de série
  • Description du dispositif
    K-Tips - Important Safety Information from Roche Diagnostics GmbH
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH