Events

Recall of THERASCREEN: K-RAS MUTATION KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by QIAGEN MANCHESTER LTD.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62560
  • Event Risk Class
    III
  • Event Initiated Date
    2010-12-01
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A customer complaint was received for therascreen: k-ras mutation kit lot dk 262-01 which confirmed a labelling error with taq polymerase one of the components packaged within the kit. the therascreen: k-ras mutation kit lot dk 262-01 is correctly labelled with an expiration date of 27 april 2011 however the taq polymerase (taq) packaged within the kit is incorrectly labelled with an expiration date of 28 february 2011.

Device

THERASCREEN: K-RAS MUTATION KIT
  • Model / Serial
    Model Catalog: 05366259190 (Lot serial: DK-262-01); Model Catalog: 05366259190 (Lot serial: DK262-01); Model Catalog: KR-41 (Lot serial: DK262-01); Model Catalog: KR-41 (Lot serial: DK-262-01)
  • Product Description
    THERASCREEN: K-RAS MUTATION KIT
  • Manufacturer
    QIAGEN MANCHESTER LTD

Manufacturer

QIAGEN MANCHESTER LTD
  • Manufacturer Address
    MANCHESTER
  • Manufacturer Parent Company (2017)
    QIAGEN N.V.
  • Source
    HC