Events

Recall of ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. 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-2016-RN-00561-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00561-1
  • 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
    Predictive quality assurance monitoring of architect stat high sensitive troponin-i reagent lots was initiated following a field action on a single lot of architect stat high sensitive troponin-i reagent in january, which impacted only selected countries. as a result, abbott has identified a potential for increased calibration failures prior to the expiration date. there is no impact to generated patient results. there is a potential for delay in results due to calibration errors and failure to calibrate which may lead to delayed treatment of life threatening injury.
  • Action
    Abbott is advising users that for certain lots, affected products can be used provided the calibration passes. Alternative lots should be ordered as soon as possible, and if the calibration fails to use an alternative lot. Once an unaffected lot is available, any remaining affected lots should be discarded. For certain lots, the expiration date should be amended as instructed. The expiration date for these lots will need to be manually tracked, as the system will maintain the original expiry date. Abbott is advising users that all new stock will have the expiry dates lowered to 4 months until corrective actions can be implemented. This action has been closed-out on 28/02/2018.

Device

ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. An in vitro diagnostic medical device (IVD)100 Test KitList Numbers: 3P25-25, 3P25-26Multiple Lot Numbers affected500 Test KitList Numbers: 3P25-35, 3P25-36Multiple Lot Numbers affectedARTG Number: 208227
  • 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