Events

ARCHITECT I SYSTEM - INTACT PTH REAGENT ASSAY 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    130150
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-02-13
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. 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 Canada.
  • 데이터 추가 비고
  • 원인
    A performance shift was observed in the architect intact pth assay that has the potential to generate falsely elevated results on patient samples. results generated in a study using current in-date reagent and calibrator lots demonstrated a magnitude of shift relative averaging approximately 13% to 45% when compared to package insert data. the shift was observed across the full analytical range of the assay.

Device

ARCHITECT I SYSTEM - INTACT PTH REAGENT ASSAY
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 8K25-25 (Lot serial: ALL LOTS); Model Catalog: 8K25-20 (Lot serial: ALL LOTS); Model Catalog: 8K25-01 (Lot serial: ALL LOTS); Model Catalog: 8K25-10 (Lot serial: ALL LOTS)
  • 제품 설명
    ARCHITECT I SYSTEM - INTACT PTH REAGENT ASSAY
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • 제조사 주소
    MISSISSAUGA
  • 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
    HC