Events

Recall of Prosigna Breast Cancer Prognostic Gene Signature Assay. 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 Bio-Strategy Pty Ltd.

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-2017-RN-00563-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-05-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00563-1
  • 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 nanostrong technologies has identified a quality issue with a single lot of the prosigna kit that may result in an error 35 of the prosigna assay due to high background. a specific failure mode has been observed at an elevated rate with prosigna kit lot 0100531017. this failure mode is pre-emptively identified by the embedded software, resulting in the output of an error by the system without the output of any test result. if this failure mode is experienced, a result for the sample would not have been obtained. if a test result was generated using this lot of kits, those results are not affected.
  • Action
    Bio-Strategy is advising users to quarantine and place all unused kits from lot 0100531017 in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection and replacement of unused kits.

Device

Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD)Product Codes: NANPROSIGNA-002, NANPROSIGNA-003Lot Number: 0100531017ARTG Number: 226487
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd