Events

Field Safety Notices about gabControl D-Dimer rapid test

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 gabmed GmbH.

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
    2016-10-18
  • 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
    Due to weakly visible test lines in the said batches, it came to an increased amount of false-negative results. although the potential risk is considered to be minor with a test considered to be a pre diagnostic test, the product is being recalled from the european market by the gabmed gmbh as a precautionary measure to prevent false negative results. as the test is used as an aid in diagnosis, there is residual risk that additional .

Device

gabControl D-Dimer rapid test
  • Model / Serial
    M09DD02 D-Dimer rapid test DIM16070008 04-2018 M09DD02 D-Dimer rapid test DIM16070007 04-2018 M09DD02 D-Dimer rapid test DIM16050005 04-2018 M09DD02 D-Dimer rapid test DIM16050004 04-2018 M09DD02 D-Dimer rapid test DIM16030006 03-2018 M09DD02 D-Dimer rapid test DIM16030001 02-2018 M09DD02 D-Dimer rapid test DIM16020004 12-2017 M09DD02 D-Dimer rapid test DIM16010006 12-2017 M09DD02 D-Dimer rapid test DIM16010003 11-2017 M09DD02 D-Dimer rapid test DIM16010002 12-2017 M09DD02 D-Dimer rapid test DIM15120003 11-2017 M09DD02 D-Dimer rapid test DIM15100003 10-2017 M09DD02 D-Dimer rapid test DIM15050008 05-2017 M09DD02 D-Dimer rapid test DIM15050007 05-2017 M09DD02 D-Dimer rapid test DIM15050006 05-2017 M09DD02 D-Dimer rapid test DDI150303 03-2017 M09DD02 D-Dimer rapid test DDI150302 03-2017 M09DD02 D-Dimer rapid test DDI141202 12-2016 M09DD02 D-Dimer rapid test DIM15060002 05-2017 M09DD02 D-Dimer rapid test DIM15060001 05-2017
  • Manufacturer
    gabmed GmbH

Manufacturer

gabmed GmbH
  • 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