Events

Recall of ARCHITECT Intact Parathyroid (PTH) 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 Abbott Australasia Pty Ltd Diagnostic Division.

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-2014-RN-00164-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00164-1
  • 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
    Abbott has confirmed that a performance shift in the architect intact parathyroid (pth) assay has the potential to generate falsely elevated results on patient samples.Results generated with impacted lots may demonstrate a positive shift averaging approximately 13% to 45% relative to those generated with previous reagent and/or calibrator lots. the issue may also impact your established architect intact pth reference ranges.
  • Action
    Abbott is advising users to immediately discontinue use and discard affected stock and to identify an alternative method of testing patient samples. Abbott is recommending the letter is reviewed with the treating physician to determine if re-evaluation of the patient is required. This action has been closed-out on 02/02/2016.

Device

ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD) List Number: 8K25 Reagent List Numbers: 8K25-20, 8K25-25 Calibrator List Numbers: 8K25-01Control List Numbers: 8K25-10Multiple Lot Numbers affected
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Abbott Australasia Pty Ltd Diagnostic Division
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA