Events

Recall Or Safety Alert for Reagents for analyzers modular immunochemical and biochemical ARCHITECT: reagent kit ARCHITECT T3 General / ARCHITECT Total T3 Reagent Kit (Lot: 38901UI00, 38901UI01)

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Diagnostics Division, Ireland.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety alert
  • Event Number
    ИМ-7.97735
  • Date
    2014-09-23
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Extra notes in the data
  • Reason
    Abbott decided to report the recall of the architect total t3 reagent kit (lot: 38901ui00, 38901ui01), and provide instructions on the actions that should be taken. the company has determined that 17% of the reagents of the two lots listed above may show lower relative light units (rlu) than expected, which in turn may affect the results of patient analyzes and make the indicators higher than expected. if you use or have reagent kits from lots 38901ui00 or 38901ui01, you should: stop using and destroy all remaining reagent kits according to your laboratory procedures; review previously obtained patient test results.

Device

Reagents for analyzers modular immunochemical and biochemical ARCHITECT: reagent kit ARCHITECT T3...

Manufacturer

Diagnostics Division, Ireland
  • 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
    MHRB