Events

Recall of Architect Toxo IgM Assay

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-01517-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01517-1
  • 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
    Abbott diagnostics has identified an issue with the architect toxo igm assay where an increase in grayzone and/or false reactive results have been observed for samples from immunocompromised patients or newborns as well as cord blood samples for certain lot numbers. these sample types share the commonality of low total igm titer. internal studies with the architect toxo igm assay have shown that pregnant women samples and serum and plasma blood donor samples are not impacted and meet assay specificity claims.Assay sensitivity is not impacted. there is the potential for false reactive patient results that may be due to reduced specificity in low total igm titer samples (eg. samples from immunocompromised patients or newborns or cord blood samples).
  • Action
    Users are advised to review the letter with their Medical Director. Additional testing with a secondary method is recommended to confirm reactive results (= 0.60 Index or = 1.00 S/CO) for samples from immunocompromised patients or newborns or cord blood samples and other samples with expected low IgM concentrations. Abbott has identified a solution to address this issue with a planned product modification expected in Q1 2017.

Device

Architect Toxo IgM Assay
  • Model / Serial
    Architect Toxo IgM AssayList Number: 6C20-25Lot Numbers: 64245LI00 (Exp.: 12/04/2017), 66063LI00 (Exp.: 13/05/2017), 67003LI00 (Exp.: 12/05/2017), 68443LI00 (Exp.: 19/07/2017)ARTG Number: 188821
  • 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