Events

Recall of PerkinEllmer LifeCycle for Prenatal Screening

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by PerkinElmer.

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
    12921
  • Event Initiated Date
    2012-12-03
  • 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: SciMed Ltd, Unit 2, 1 Tussock Lane, Ferrymead, Christchurch 8023
  • Reason
    Perkin elmer has become aware about lifecycle risk calculation problem that can potentially take place with assisted reproduction screening where an egg donor is involved. the change in calculated risk is dependent on the age difference between the mother and the egg donor. in the worst case, if the age of the mother is substantially higher than the egg donor's age. a true low risk value can be turned as high and thereby cause indirect harm because of possibility for an unnecessary medical intervention.
  • Action
    Software to be upgraded

Device

PerkinEllmer LifeCycle for Prenatal Screening
  • Model / Serial
    Model: 5002-0020, Affected: Software versions 3.0, 3.1, 3.2
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer