Events

Field Safety Notices about Architect Intact PTH Reagent Kit, Architect Intact PTH Controls, Architect Intact PTH Calibrators

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
    2014-11-02
  • Event Date Posted
    2014-02-28
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/02/28/6168/
  • 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 results obtained using the affected batches may be falsely elevated and that may indicate a positive shift over the results obtained. using previous batches of reagents and / or calibrators. this shift may affect reference intervals of the architect intact pth test determined in a particular laboratory, whereby abbott architect intact pth controls do not detect displacement. as regards the diagnosis of diseases related to disorders of calcium metabolism, these false elevated results may lead the doctor to think that the patient is suffering from hyperparathyroidism, or to fail to diagnose hypoparathyroidism. these findings would be inconsistent with the clinical picture and / or with the results of other tests and could lead to new patient testing and short-term placement delays diagnoses in chronic diseases.

Device

Architect Intact PTH Reagent Kit, Architect Intact PTH Controls, Architect Intact PTH Calibrators
  • Model / Serial
    ARCHITECT Intact PTH 8K25-01 Calibrator 006131000 05 SEP 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 01913C000 14 MAR 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 01913K000 12 NOV 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 02413E000 09 MAY 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 01312K000 12 NOV 2013 ARCHITECT Intact PTH 8K25-01 Calibrator 00813AOOO 08 JAN 2014 ARCHITECT Intact PTH 8K25-01 Calibrator 01412H000 16 AUG 2013 ARCHITECT Intact PTH 8K25-01 Calibrator 00912F000 30 MAY 2013 ARCHITECT Intact PTH 8K25-10 Control 007131000 05 SEP 2014 ARCHITECT Intact PTH 8K25-10 Control 01813C000 14 MAR 2014 ARCHITECT Intact PTH 8K25-10 Control 01813K000 12 NOV 2014 ARCHITECT Intact PTH 8K25-10 Control 02613E000 09 MAY 2014 ARCHITECT Intact PTH 8K25-10 Control 01412K000 12 NOV 2013 ARCHITECT Intact PTH 8K25-10 Control 00713A000 08 JAN 2014 ARCHITECT Intact PTH 8K25-10 Control 01012F000 30 MAY 2013 ARCHITECT Intact PTH 8K25-20 Reagent 00913F000 23 NOV 2014 ARCHITECT Intact PTH 8K25-20 Reagent 01313C000 21 AUG 2014 ARCHITECT Intact PTH 8K25-20 Reagent 01512K000 25 APR 2014 ARCHITECT Intact PTH 8K25-20 Reagent 01712H000 23 FEB 2014 ARCHITECT Intact PTH 8K25-20 Reagent 018131000 13 MAR 2015 ARCHITECT Intact PTH 8K25-20 Reagent 02213K000 08 MAY 2015 ARCHITECT Intact PTH 8K25-20 Reagent 01312G000 13 JAN 2014 ARCHITECT Intact PTH 8K25-20 Reagent 00512H000 13 JAN 2014 ARCHITECT Intact PTH 8K25-25 Reagent 00112K000 25 APR 2014 ARCHITECT Intact PTH 8K25-25 Reagent 01113C000 21 AUG 2014 ARCHITECT Intact PTH 8K25-25 Reagent 01313G000 05 JAN 2015 ARCHITECT Intact PTH 8K25-25 Reagent 01612H000 23 FEB 2014 ARCHITECT Intact PTH 8K25-25 Reagent 019131000 02 FEB 2015 ARCHITECT Intact PTH 8K25-25 Reagent 02213D000 05 OCT 2014 ARCHITECT Intact PTH 8K25-25 Reagent 00113K000 11 APR 2015 ARCHITECT Intact PTH 8K25-25 Reagent 01212G000 13 JAN 2014 ARCHITECT Intact PTH 8K25-25 Reagent 00412H000 13 JAN 2014 ARCHITECT Intact PTH 8K25-27 Reagent 00212K000 25 APR 2014 ARCHITECT Intact PTH 8K25-27 Reagent 01213C000 21 AUG 2014 ARCHITECT Intact PTH 8K25-27 Reagent 01413G000 05 JAN 2015 ARCHITECT Intact PTH 8K25-27 Reagent 01812H000 23 FEB 2014 ARCHITECT Intact PTH 8K25-27 Reagent 020131000 02 FEB 2015 ARCHITECT Intact PTH 8K25-27 Reagent 02313D000 05 OCT 2014 ARCHITECT Intact PTH 8K25-27 Reagent 00213K000 11 APR 2015 ARCHITECT Intact PTH 8K25-27 Reagent 01412G000 13 JAN 2014 ARCHITECT Intact PTH 8K25-27 Reagent 00612H000 13 JAN 2014
  • 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