Events

Safety Alert for HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0

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.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-03-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120316.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
    Field safety notice: abbott molecular hcv genotype ii m2000 system row combined application cd-rom version 3.0 medical device manufacturer, abbott molecular inc., has issued a field safety notice concerning hcv genotype ii m2000 system row combined application cd-rom version 3.0 (list no: 8l36-03). according to the manufacturer, internal software development testing identified that when running the hcv-gt ii assay, if four or more genotype calls are present for a sample, the software does not generate a result (printed or displayed). instead a blank field is reported. this observation will only occur when running: m2000rt instrument system software v4.0 and v5.0 and hcv genotype ii m2000 system row combined application cd-rom version 3.0. there have been no reports from customers in regards to this observation. if you are in possession of the products, please contact your supplier for necessary action.

Device

HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Molecular HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0
  • Manufacturer
    Abbott Molecular Inc.

Manufacturer

Abbott Molecular Inc.
  • 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