Events

Safety Alert for m2000sp Instrument

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott Molecular.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-10-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111013b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Urgent field safety notice: abbott m2000sp instrument medical device manufacturer, abbott molecular, issued an urgent field safety notice concerning m2000sp instrument (list number: 9k14). there have been two reported instances in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated or caught fire. in both cases the event was contained within the lower cabinet of the m2000sp. there were no reported injuries. abbott molecular is actively investigating this issue. according to the local supplier, the affected device has been distributed to hk. abbott molecular recommends users to examine the liquid waste sensor during daily maintenance, and stop using the system when any unusual conditions noticed and contact the local supplier for service. if you are in possession of the affected product, please contact your supplier immediately for necessary actions.

Device

m2000sp Instrument
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott m2000sp Instrument
  • Manufacturer
    Abbott Molecular

Manufacturer

Abbott Molecular
  • 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
    DH