Events

Recall of IMX SYSTEM - GLYCATED HEMOGLOBIN REAGENT

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
    20429
  • Event Risk Class
    II
  • Event Initiated Date
    2000-02-28
  • 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
    Abbott received an increased number of complaints for the imx glycated hemoglobin assay for error messages of "****" and/or "<3.61% ghb".

Device

IMX SYSTEM - GLYCATED HEMOGLOBIN REAGENT
  • Model / Serial
    Model Catalog: 1A86-88 (Lot serial: 60277M300 60278M300.); Model Catalog: 1A86-88 (Lot serial: 60275M300 60276M300); Model Catalog: 1A86-88 (Lot serial: 59545M200 60274M300); Model Catalog: 1A86-88 (Lot serial: 58157M400 58332M200); Model Catalog: 1A86-88 (Lot serial: 57411M200 58079M100); Model Catalog: 1A86-88 (Lot serial: 56566M200 56568M200)
  • Product Description
    IMX GLYCATED HEMOGLOBIN
  • 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