Events

Recall of DELFIA Xpress PlGF Kit

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-00629-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00629-1
  • 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
    Perkin elmer has become aware that the stability of the plgf calibrators lot 637341 is impaired. the stability issue is limited to one lot of plgf calibrators. due to the impaired stability a decreasing trend in the signal level measured for the plgf calibrators occurs; the signal level of the plgf calibrators lot 637341 has decreased an average of 20% since release. the signal decrease results in the measured plgf concentrations for the qc controls and patient samples will be falsely high, expected increase is approximately +20%. perkin elmer investigations have identified the impaired stability of the plgf calibrators is due to an issue in the quality of a single batch of the raw material used in the manufacture of the plgf calibrators.
  • Action
    Perkin Elmer is requesting the customers to check their inventory, immediately discontinue use and destroy all the affected DELFIA Xpress PlGF kit lots. PerkinElmer will replace all DELFIA Xpress PlGF Kits of the designated lots in the inventory. Perkin Elmer is further requesting the customers to review and repeat patient samples, if PlGF control values for completed DELFIA Xpress PlGF runs with the affected product lots are not within the established acceptance range. This action has been closed-out on 04/05/2017.

Device

DELFIA Xpress PlGF Kit
  • Model / Serial
    DELFIA Xpress PlGF Kit Catalogue numbers: 6007-002CProduct Lot numbers: 1063782701ARTG Number: 198244
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer