Events

Recall of MULTIGENT Ammonia Ultra Reagent. 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-2015-RN-00955-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00955-1
  • 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
    Due to a manufacturing issue with multigent ammonia ultra reagent, list number 6k89-30, lot 50083y600 are being removed from use. this lot is producing results below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. quality control results are not affected. complaints relating to out of range patient results have been confirmed through internal testing as no measurable ammonia values were obtained for samples tested per package insert instructions. a review of complaint data for the impacted lot of ammonia also indicates there is potential for lower than expected results to be generated, however, this has not been confirmed during internal testing. based on testing of all in-date lots no other reagent lots or sample tube types are known to be impacted.
  • Action
    Users are requested to inspect their stock and destroy any inventory affected by this recall. Abbott is advising users to follow laboratory protocol regarding the review of previously generated patient results. This action has been closed-out on 26/08/2016.

Device

MULTIGENT Ammonia Ultra Reagent. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    MULTIGENT Ammonia Ultra Reagent. An in vitro diagnostic medical device (IVD)List Number: 6K89-30Lot Number: 50083Y600Expiration Date 31 Jul 2016ARTG Number: 203299
  • 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