Events

Recall of LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia 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
    RC-2013-RN-00843-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00843-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has become aware of an unexpected behaviour in how the lifecycle risk calculation engine (elipse) accepts and utilizes the ethnic factor given by the user. if the ethnic factor has been changed from a valid numeric value to "0" (zero) the case risk will not be calculated by applying the latest validated median equation as intended by the user.
  • Action
    PerkinElmer is advising users to replace the default median equations supplied at installation with laboratory-specific ones and maintain the Marker Medians-form to ensure the Ethnic Factor values are greater than zero. PerkinElmer are recommending users update the software to version 4.0 rev 2. A review of past results should be made on a case by case bases as recommended by PerkinElmer.

Device

LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).Catalogue numbers: 5002-0020Software version: v2.1, v2.2, v3.0, v3.1, v3.2 (including all revisions)
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer