Events

Recall of MULTIGENT Creatinine (Enzymatic) assay. 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-2017-RN-00731-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00731-1
  • 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
    The manufacturer sentinel has confirmed a performance issue with three specific lots of multigent creatinine (enzymatic) reagent which may result in quality control values shifting out of acceptable ranges or erratic patient results, and this issue is not resolved through recalibration.Sentinel has determined that although the probability of occurrence is remote, a potential delay may exist in the generation of patients' results due to quality control values falling outside of expected ranges. internal investigations made on quality controls showed a variability from -26% to +4% for serum samples and from -20% to +4% for urine samples.
  • Action
    Abbott is advising users to discontinue use of the impacted lots immediately and destroy any remaining inventory of impacted lots according to their laboratory procedures. If you have an alternate reagent lot available in inventory, switch to this alternate lot, or use a new lot provided. The customer letter is to be reviewed with the laboratory Medical Director.

Device

MULTIGENT Creatinine (Enzymatic) assay. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    MULTIGENT Creatinine (Enzymatic) assay. An in vitro diagnostic medical device (IVD)List Number: 8L24-31Lot Numbers: 60335Y600 and 60382Y600List Number: 8L24-41Lot Number: 60334Y600Expiry Date: 28 Feb 2018ARTG 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