Events

Recall of AXSYM SYSTEM - IMMUNOASSAY ANALYZER CLASS 2

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
    92491
  • Event Risk Class
    III
  • Event Initiated Date
    2002-03-03
  • 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
    The manufacturer has received complaints for calibration error codes and control values out of range high.

Device

AXSYM SYSTEM - IMMUNOASSAY ANALYZER CLASS 2
  • Model / Serial
    Model Catalog: 8A46-01 (Lot serial: 81865M300 81868M300 81870M3O); Model Catalog: 8A46-01 (Lot serial: 1 80074M200 80075M200 80296); Model Catalog: 8A46-01 (Lot serial: 81873M300 81871M300 79809M10); Model Catalog: 8A46-01 (Lot serial: M300 AND 81026M300.); Model Catalog: 8A46-01 (Lot serial: 0 81860M300 81861M300 81862); Model Catalog: 8A46-01 (Lot serial: 81856M300 81857M300 81858M30); Model Catalog: 8A46-01 (Lot serial: M300 81841M300 81855M300); Model Catalog: 8A46-01 (Lot serial: 0 81832M300 81839M300 81840); Model Catalog: 8A46-01 (Lot serial: 81040M300 81041M300 81831M30); Model Catalog: 8A46-01 (Lot serial: 81852M300 81854M300 81022M30); Model Catalog: 8A46-01 (Lot serial: M300 81027M300 81038M300); Model Catalog: 8A46-01 (Lot serial: 0 81023M300 81024M300 81025); Model Catalog: 8A46-01 (Lot serial: M300 81846M300 81851M300); Model Catalog: 8A46-01 (Lot serial: 0 81844M300 81869M300 81845); Model Catalog: 8A46-01 (Lot serial: 81029M300 81030M300 81843M30); Model Catalog: 8A46-01 (Lot serial: M300 810
  • Product Description
    AXSYM SOLUTION 4 LINE DILUENT
  • 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