Events

Recall of i-STAT1 Analyser when used with i-STAT Celite Activated Clotting Time (ACT) & Kaolin ACT Cartridges. An in vitro diagnostic medical device (IVD).i-STAT1 Analyser – software version JAMS142E i-STAT Celite ACT Cartridges

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abbott Australasia Pty Ltd Point-of-Care 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-2017-RN-00225-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-02-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00225-1
  • 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 point of care inc. has determined that celite act and kaolin act cartridges may produce falsely low results when very high clotting time samples are tested when using i-stat1 analyser software version jams142e. patient samples with a measured clot time of >853 seconds for celite and >1134 seconds for kaolin may display results of approximately 100 to 200 seconds. the typical therapeutic range of the i-stat act assay is 200 to 600 seconds and results in this range are not affected by this issue. only individual patient results where the measured clot time is >853 seconds for celite act and >1134 seconds for kaolin act are impacted. the i-stat system provides the user with an ongoing estimate of the clot time as the act cartridges are running, referred to as the count up bar. the count up bar is not impacted by this issue. the ongoing estimates that the user receives during the cartridge run are correct.
  • Action
    To correct the issue, Abbott is advising customers to update all i-STAT analysers performing Celite ACT or Kaolin ACT testing with software version JAMS142G, which is available from the Abbott Point of Care website. A look back of results is not required, as results obtained within the typical therapeutic range of 200 to 600 seconds are not affected, only individual patient results where the measured clot time is >853 seconds for Celite ACT and >1134 seconds for Kaolin ACT are impacted and monitoring of the activated clotting time is happening in real time during a procedure. This action has been closed-out on 04/07/2017.

Device

i-STAT1 Analyser when used with i-STAT Celite Activated Clotting Time (ACT) & Kaolin ACT Cartridg...
  • Model / Serial
    i-STAT1 Analyser when used with i-STAT Celite Activated Clotting Time (ACT) & Kaolin ACT Cartridges. An in vitro diagnostic medical device (IVD).i-STAT1 Analyser – software version JAMS142E i-STAT Celite ACT CartridgesList Number: 03P86-25i-STAT Kaolin ACT CartridgesList Number: 03P87-25ARTG Numbers: 203350, 213851
  • Manufacturer
    Abbott Australasia Pty Ltd Point-of-Care Division

Manufacturer

Abbott Australasia Pty Ltd Point-of-Care 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