Events

Recall of i-STAT Kaolin ACT Cartridges

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Abbott Point of Care Canada 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
    22423
  • Event Initiated Date
    2018-01-11
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Abbott Australasia Pty Ltd (NZ), Abbott Laboratories NZ, 4 Pacific Rise, Mt Wellington, Auckland 1060
  • Reason
    To regards to the drug aprotinin (trasylol), which was previously withdrawn from many markets but may be available in some countries/regions. internal studies, have identified that the i-stat kaolin act test may be prolonged immediately after the administration of an initial full dose aprotinin bolus of 400 kallikrein inhibitor units (kiu)/ml. once the drug has fully distributed throughout the body there is no impact on the act result reported. for aprotinin, 200-280 kiu/ml is considered a therapeutic or steady state concentration during cpb.
  • Action
    Manufacturer to issue advice regarding use

Device

i-STAT Kaolin ACT Cartridges

Manufacturer

Abbott Point of Care Canada Ltd
  • 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
    NZMMDSA