Events

Recall of Leica Ki67-MM1 Bond RTU

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Leica Biosystems Newcastle 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
    18387
  • Event Initiated Date
    2015-04-20
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Leica Microsystems Pty Ltd, Unit 3, 112-118 Talavera Road, North Ryde, NSW 2113, AUSTRALIA
  • Reason
    Leica biosystems recently became aware that the affected lots identified do not consistently perform as expected and in some instances have exhibited weaker than expected staining.
  • Action
    Product to be destroyed

Device

Leica Ki67-MM1 Bond RTU
  • Model / Serial
    Model: Product Code: PA0118 and KI67-MM1-L-CE, Affected: Lots: 28251, 29784, 29879, 29880, 30673, 30683 (PA0118); and 6031742, 6027899 (KI67-MM1-L-CE)
  • Manufacturer
    Leica Biosystems Newcastle Ltd

Manufacturer

Leica Biosystems Newcastle Ltd