Events

Recall of Abbott RealTime High Risk HPV and RealTime High Risk (HR) HPV Application CD-ROM (for m2000 System)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Abbott Molecular Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    15700
  • Event Initiated Date
    2013-11-21
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Abbott Diagnostics Division, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, AUCKLAND 1640
  • Reason
    M2000rt instrument noise is defined as an unexpected cycle-to-cycle variability in the flurorescence signals during the amplification and detection process. abbott molecular has identified that the instrument noise lower limit validy parameter for the realtime hr hpv assay is set outside of the optinal setting to flag excess variability in fluroescence signal. therefore, in the presence of excess noise, incorrect results could be generated.
  • Action
    Software to be upgraded

Device

Abbott RealTime High Risk HPV and RealTime High Risk (HR) HPV Application CD-ROM (for m2000 System)
  • Model / Serial
    Model: List Numbers: 02N09 & 4N05-01, Affected: Version 1.0
  • 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
    NZMMDSA