Events

Field Safety Notices about Alere HIV Combo

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Alere.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-07-14
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Patients may be exposed to unnecessary treatment if the instructions for use and other requirements for testing the algorithms are not followed closely, and if clinical measures are taken on the original p24 antigen-positive sample.   with this safety notice, we want to inform users that tests from the series below are more likely to detect the presence of p24 antigen, and to remind them of the recommendation in the package leaflet to confirm all initially positive results (indicating the presence of p24 antibodies and / or antigen) by the second method.

Device

Alere HIV Combo
  • Model / Serial
    Alere HIV Combo 78169K100 7D2842 7D2843 7D2846 7D2847 7D2843SET 7D2843SET 78169K100E 78169K100A 78169K100C 78169K100B 78169K100R 78169K100S 79290K100 7D2843SET 79290K100R 79291K100 7D2843SET 79291K100R 79292K100 7D2843SET 79292K100R 79293K100 7D2842 7D2843 7D2843 7D2843SET 79293K100C 79293K100A 79293K100B 79293K100R AlertJ
  • Manufacturer
    Alere

Manufacturer

Alere
  • 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
    AMPMDRS