Events

Recall of i-STAT 1 Analyser Software with i-STAT Total â-hCG Cartridge with software version JAMS 143/CLEW A34. 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 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-01411-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01411-1
  • 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
    Through a combination of internal studies and customer reports, abbott point of care has determined that users may experience an increased frequency of quality check code 149 when testing i-stat total ß-hcg cartridges with i-stat 1 analyser software version jams 143 / clew a34. there is no impact on user/patient safety. due to the fact that quality check code 149 requires the test to be repeated, this issue has the potential to delay generation of i-stat total ß-hcg results.
  • Action
    Abbott is advising facilities performing testing with i-STAT Total ß-hCG cartridges, to verify that all i-STAT analysers performing i-STAT Total ß-hCG testing have been updated to software version JAMS 144 / CLEW A35. If the software has not yet been updated to version JAMS 144 / CLEW A35, please follow the directions on the Abbott Point of Care website (see link below) for the installation of the software. https://www.pointofcare.abbott/us/en/offerings/support/software-license-keys/istat-system-software-update .

Device

i-STAT 1 Analyser Software with i-STAT Total â-hCG Cartridge with software version JAMS 143/CLEW ...
  • Model / Serial
    i-STAT 1 Analyser Software with i-STAT Total â-hCG Cartridge with software version JAMS 143/CLEW A34. An in vitro diagnostic medical device (IVD) ARTG Number: 203349 (Abbott Australasia Pty Ltd (Point-of-Care Division) - Clinical chemistry hormone IVDs)
  • 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