Events

Architect Intact PTH Reagent Kit, Architect Intact PTH Controls, Architect Intact PTH Calibrators 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 Abbott GmbH & Co. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2014-11-02
  • 사례 출판 날짜
    2014-02-28
  • 사례 국가
    Serbia
  • 사례 출처
    ALIMSA
  • 사례 출처 URL
    https://www.alims.gov.rs/latin/2014/02/28/6168/
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “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