Events

Recall of LifeCycle for Prenatal Screening software

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-2015-RN-00999-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00999-1
  • 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 issue was caused by an unintended rounding of the median equation factors that led to inadequate number of significant digits (decimals) in the default median equation. the equation was originally introduced in lifecycle version v4.0 rev4. due to the issue, the inhibin a mom level of an unaffected population was observed to be approximately half from what it should have been. this unintended rounding error was observed internally and no customer complaints have been received.
  • Action
    Perkin Elmer is providing users with instructions to correct the error. Alternatively, Perkin Elmer can implement the correction at the affected site. This action has been closed-out on 19/08/2016.

Device

LifeCycle for Prenatal Screening software
  • Model / Serial
    LifeCycle for Prenatal Screening softwareCatalogue Number: 5014-0020 Version Number: v4.0 Rev4ARTG Number: 216895
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer