Events

ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abbott Australasia Pty Ltd 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
    RC-2014-RN-00164-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00164-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Abbott has confirmed that a performance shift in the architect intact parathyroid (pth) assay has the potential to generate falsely elevated results on patient samples.Results generated with impacted lots may demonstrate a positive shift averaging approximately 13% to 45% relative to those generated with previous reagent and/or calibrator lots. the issue may also impact your established architect intact pth reference ranges.
  • 조치
    Abbott is advising users to immediately discontinue use and discard affected stock and to identify an alternative method of testing patient samples. Abbott is recommending the letter is reviewed with the treating physician to determine if re-evaluation of the patient is required. This action has been closed-out on 02/02/2016.

Device

ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    ARCHITECT Intact Parathyroid (PTH) Assay. An in vitro diagnostic medical device (IVD) List Number: 8K25 Reagent List Numbers: 8K25-20, 8K25-25 Calibrator List Numbers: 8K25-01Control List Numbers: 8K25-10Multiple Lot Numbers affected
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Abbott Australasia Pty Ltd Diagnostic Division
  • 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
    DHTGA