Events

Recall of Clinical Chemistry ICT Serum Calibrator. 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-00828-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00828-1
  • 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
    An abbott investigation has identified that the ict serum calibrator lots above may generate lower than expected potassium qc and patient results. a potential cause of this issue is increased ammonia content over the shelf life of the calibrator. elevated ammonia concentration may impact the potassium calibration and potentially cause a calibration curve to generate the lower results. patient results may have shifted down by 1-3% beyond the acceptable performance of the assay.
  • Action
    Abbott is advising their customers that if the calibration curve for Potassium is verified with at least two levels of controls according to established quality control requirements for the laboratory, continue to use the lot until new lots are received through the normal ordering processes. If QC results for Potassium are not within established quality control requirements, uses are advised to recalibrate using a different calibrator lot. This action has been closed-out on 03/02/2017.

Device

Clinical Chemistry ICT Serum Calibrator. An in vitro diagnostic medical device (IVD)

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