Events

Field Safety Notices about ARCHITECT DHEA-S Reagent Kit

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Abbott GmbH & Co.

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
    2017-12-14
  • Event Date Posted
    2018-01-29
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2018/01/29/vazno-obavestenje-o-medicinskom-sredstvu-architect-dhea-s-reagent-kit-imunohemija/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The manufacturer has identified that, when using the architect dhea-s reagent kit, samples from babies up to 60 days of age may have false results. the manufacturer is currently investigating the specific cause of the elevated results. although false elevations have been observed in infants up to 60 days of age, the reference range for children up to 10 years of age given in the test instruction manual should also not be used as the reference ranges are being tested.

Device

ARCHITECT DHEA-S Reagent Kit
  • Model / Serial
    (8K27-20) 01316K000; 01217A000; 02217D000; 04117H000;(8K27-25)01216K000; 01117A000; 02217C000; 02317D000; 02417D000; 00517F000; 02817H000
  • Manufacturer
    Abbott GmbH & Co

Manufacturer

Abbott GmbH & Co
  • 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
    ALIMSA