Events

Recall of LifeCycle for Prenatal Screening, Version 4.0 Revisions 2, 3 and 4. 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-2016-RN-00413-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00413-1
  • 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 above software version has an incorrectly defined calculation parameter in one of the proportion equations for ductus venosus pulsatility index (dvpi). dvpi was originally introduced in lifecycle version v4.0 rev2.The issue is caused by an unintended error in the normal likelihood crown – rump length (crl) independent proportion equation. the equation contains parameter crl instead of the correct parameter crl - 65. due to the issue, the obtained risk value is approximately four times higher than expected with mothers having high measured dvpi (dvpi = 1.5). risk calculation results are not affected when measured dvpi is lower than 1.5. the issue may increase the false positive rate of t13, t18 and t21 screening in case dvpi is applied in the risk calculation. in case the measured dvpi is greater than 1.5, a false high risk screening result is reported.
  • Action
    PerkinElmer is recommending that users immediately discontinue applying the DVPI in the routine screening program and review any high risk screening results in which the measured DVPI is = 1.5. These risk calculation results are not considered accurate and should be recalculated without applying the DVPI in risk calculation. A software update will be provided as a permanent correction. This action has been closed-out on17/02/2017.

Device

LifeCycle for Prenatal Screening, Version 4.0 Revisions 2, 3 and 4. An in vitro diagnostic medica...
  • Model / Serial
    LifeCycle for Prenatal Screening, Version 4.0 Revisions 2, 3 and 4. An in vitro diagnostic medical device (IVD)Catalogue number (order code): 5014-0020ARTG number: 216895
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer