Events

Field Safety Notices about K-Tips

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Roche Diagnostics GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2009-11-05
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    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 / Alerts
    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.
  • Extra notes in the data
    3rd Party Publications
  • Reason
    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
  • Model / Serial
  • Product Description
    K-Tips - Important Safety Information from Roche Diagnostics GmbH
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH