Safety Alert for m2000sp instrument

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

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
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Medical device safety alert: abbott laboratories m2000sp instrument medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning m2000sp instrument, with affected list number 09k14. all assays run on the m2000sp instrument that require manual entry of calibrator and control expiration dates, lot numbers, and calibrator and control concentration values were affected. according to the manufacturer, there was an issue on the m2000sp instrument software when information is entered incorrectly during the creation of a sample extraction test order. an issue may occur only when the correction is made to manually entered calibrator or control information after the operator have progressed beyond the "sample extraction: sample scan" screen and the operator do not re-scan the sample tubes and racks after data correction on the "sample extraction: assay detail" screen. an issue with the m2000sp instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the sample extraction assay details screen, the changes are not saved. this software issue will occur if some specific steps are followed. furthermore, the manufacturer advises users that when entering calibrator or control information on the sample extraction: assay details screen, verify that the information is correct prior to proceeding to tile next screen. if identifying that the entered information is incorrect, users can correct the information by following options or steps suggested by the manufacturer. the manufacturer will deploy a new corrective software upgrade by the end of first quarter 2013. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 17 december 2012.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Laboratories m2000sp instrument
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • 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