Events

Field Safety Notices about ARCHITECT Toxo IgM

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 ABBOTT.

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
    2016-11-14
  • 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
    For the architect toxo igm assay an increase in grayzone and/or false reactive results have been observed for samples from immunocompromised patients or newborns as well as cord blood samples for the lot numbers above. these sample types share the commonality of low total igm titer. internal studies with the architect toxo igm assay have shown that pregnant women samples and serum and plasma blood donor samples are not impacted and meet assay specificity claims. .

Device

ARCHITECT Toxo IgM
  • Model / Serial
    6C20-25 64245LI00 2017-04-12 Not Applicable 66063LI00 2017-05-13 67003LI00 2017-05-12 68443LI00 2017-07-19 69252LI00 2017-07-19 70171LI00 2017-08-26 6C20-35 64248LI00 2017-04-12 66066LI00 2017-05-13 67006LI00 2017-05-12 68444LI00 2017-07-19 69253LI00 2017-07-19 70174LI00 2017-08-26
  • Manufacturer
    ABBOTT

Manufacturer

ABBOTT
  • 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