Safety Alert for Bar Code Scanner User’s Guide

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

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.

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  • Type of Event
    Safety alert
  • Date
  • 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
    Field safety notice: abbott molecular bar code scanner user’s guide medical device manufacturer, abbott molecular inc., has issued a field safety notice on abbott molecular bar code scanner user’s guide list number: 6l-88-03, 6l88-04, 6l88-05, 6l88-06, 6l88-07, 6l88-08, 6l88-09. according to the manufacturer, internal investigation has identified that within the user’s guide, the section modifying the keyboard format for bar code scanner ln 6l89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. the manufacturer explained that incorrect bar code scanner language configuration could result in the keyboard and bar code scanner not having the same language formats. this could potentially lead to incorrect patient sample identification. independent of this language configuration issue, the bar code scanner is working as expected. the local supplier confirmed that scanners with the affected list numbers have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Molecular Bar Code Scanner User's Guide
  • 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