Events

Recall of AXSYM SYSTEM - DIGOXIN II ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ABBOTT LABORATORIES LIMITED. 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
    91109
  • Event Risk Class
    II
  • Event Initiated Date
    2002-05-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Assay may exhibit negative interference from aldosterone inhibitors.

Device

AXSYM SYSTEM - DIGOXIN II ASSAY
  • Model / Serial
    Model Catalog: 5B73-20 (Lot serial: 1 58020Q100 58752Q100); Model Catalog: 2213-20 (Lot serial: 66535M100 84599M200 78946M10); Model Catalog: 5B73-20 (Lot serial: Q100 74213Q100 74234Q100); Model Catalog: 5B73-20 (Lot serial: 1 71567Q100 71567Q101 72160); Model Catalog: 5B73-20 (Lot serial: 70023Q101 70393Q100 70393Q10); Model Catalog: 5B73-20 (Lot serial: 0 68957Q101 70023Q100); Model Catalog: 5B73-20 (Lot serial: 68677Q100 68677Q101 68957Q10); Model Catalog: 2213-20 (Lot serial: 85763M100.); Model Catalog: 2213-20 (Lot serial: M200 80082M200 53388M300); Model Catalog: 2213-20 (Lot serial: 0 73375M200 61699M100 64599); Model Catalog: 5B73-20 (Lot serial: 1.); Model Catalog: 5B73-20 (Lot serial: 82589Q101 83777Q100 83777Q10); Model Catalog: 5B73-20 (Lot serial: Q100 81316Q101 82589Q100); Model Catalog: 5B73-20 (Lot serial: 0 80974Q101 81169Q101 81316); Model Catalog: 5B73-20 (Lot serial: 79407Q101 79811Q100 80974Q10); Model Catalog: 5B73-20 (Lot serial: Q100 78361Q100 79407Q100); Model Catalog: 5B73-20 (Lot
  • Product Description
    ABBOTT AXSYM & IMX DIGOXIN II REAGENT
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • Manufacturer Address
    MISSISSAUGA
  • 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
    HC