Events

Recall of ABBOTT M2000 SYSTEM - M2000RT INSTRUMENT

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
    37030
  • Event Risk Class
    III
  • Event Initiated Date
    2009-11-26
  • 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
    When hand-held bar code scanner is used for entering (scanning) data under condition that the computer keyboard caps lock key is enabled upper case letters encoded in the bar codes will be reported by the computer as lower case ones and lower case letters will be reported as upper case ones. additionally when hand-held bar code scanner is used for entering data under condition that some other keyboard keys are enabled data scanned can be altered such that those recognized by the m2000 may not match the codes contained on the bar code for all cases.

Device

ABBOTT M2000 SYSTEM - M2000RT INSTRUMENT
  • Model / Serial
    Model Catalog: 9K15-01 (Lot serial: all lots); Model Catalog: 9K14-01 (Lot serial: ALL LOTS); Model Catalog: 06L89-01(BAR CODE SCANNER) (Lot serial: ALL LOTS); Model Catalog: 9K14-02 (Lot serial: ALL LOTS)
  • Product Description
    BAR CODE SCANNER
  • 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