Events

Recall of INNOVANCE PFA P2Y. An in vitro diagnostic device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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-2016-RN-00019-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-01-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00019-1
  • 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
    Siemens healthcare diagnostics has confirmed that innovance pfa p2y cartridge lots 5464024, 5464025, 5464026 and 5464027 show falsely extended shelf life.Internal investigations have shown that innovance pfa p2y cartridges used beyond the correct but within the displayed shelf life date showed a maximal deviation of down to -11% which is within the overall performance claims. there is no risk to health.
  • Action
    The sponsor is advising users not to use units from the affected lots beyond the correct shelf life dates given in the customer letter. This action has been closed-out on 27/01/2017.

Device

INNOVANCE PFA P2Y. An in vitro diagnostic device (IVD)
  • Model / Serial
    INNOVANCE PFA P2Y. An in vitro diagnostic device (IVD)Catalogue Number: B4170-22Siemens Material Number (SMN): 10445700Lot Numbers: 5464024; 5464025; 5464026; 5464027ARTG Number: 178507
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA