Events

Recall of AXSYM SYSTEM - CA-125 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
    107171
  • Event Risk Class
    III
  • Event Initiated Date
    2007-05-02
  • 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
    Failure to actuate (open) some reagent packs. the following can result in probe crashes if not detected: separation of the flipper bar from the caps caps that do not remain open and broken cap hinges.

Device

AXSYM SYSTEM - CA-125 ASSAY
  • Model / Serial
    Model Catalog: 3B41-20 (Lot serial: 49467M200); Model Catalog: 2J44-20 (Lot serial: 49238M200); Model Catalog: 5C78-20 (Lot serial: 50450M100); Model Catalog: 5C78-20 (Lot serial: 48839M100); Model Catalog: 2J44-20 (Lot serial: 51411M102); Model Catalog: 2J44-20 (Lot serial: 51411M100); Model Catalog: 2J44-20 (Lot serial: 49238M203); Model Catalog: 2J44-20 (Lot serial: 49238M202); Model Catalog: 2J44-20 (Lot serial: 49238M201); Model Catalog: 3B23-20 (Lot serial: 49146M100); Model Catalog: 3C81-20 (Lot serial: 49488M200); Model Catalog: 3C81-20 (Lot serial: 50483M200); Model Catalog: 5C78-20 (Lot serial: 51252M100)
  • Product Description
    AXSYM SYSTEM - CA-125 ASSAY
  • 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