Events

Safety Alert for RealTime High Risk HPV Assay and RealTime High Risk (HR) HPV m2000 system ROW Combined Application CD-ROM

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
    2013-12-02
  • Event Date Posted
    2013-12-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131202.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
    Medical device safety alert: abbott realtime high risk hpv assay and realtime high risk (hr) hpv m2000 system row combined application cd-rom medical device manufacturer, abbott molecular inc., has issued a medical device safety alert concerning its realtime high risk hpv assay and realtime high risk (hr) hpv m2000 system row combined application cd-rom [list no.: 02n09 and 4n05-01; version 1.0 of the realtime high risk (hr) hpv m2000 system row combined application cd-rom] according to the manufacturer, m2000rt instrument noise is defined as an unexpected cycle-to-cycle variability in the fluorescence signals during the amplification and detection process. the manufacturer has identified that the instrument noise lower limit validity parameter for the realtime hr hpv assay is set outside of the optimal setting to flag excess variability in fluorescence signal. therefore, in the presence of excess noise, incorrect results could be generated. it is normal for instruments to have some variability in fluorescence signal (noise). however, one factor that could contribute to excess instrument noise is m2000rt lamp issues. a resolution has been identified and requires a change to the instrument noise validity parameter for realtime hr hpv assay. the manufacturer will correct the issue in the next version of the assay software. affected users are recommended to follow the technical solutions mentioned in the field safety notice until an upgrade to the new software can be installed. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 02 december 2013.

Device

RealTime High Risk HPV Assay and RealTime High Risk (HR) HPV m2000 system ROW Combined Applicatio...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott RealTime High Risk HPV Assay and RealTime High Risk (HR) HPV m2000 system ROW Combined Application CD-ROM
  • 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