Events

Acetaminophen (Paracetamol) Reagent (used with L3K Assay in conjunction with the Architect cSystem Analyser). 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-2016-RN-00112-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00112-1
  • 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
    The manufacturer, sekisui has investigated complaints related to the formation of crystals in the r2 reagent and/or shift of controls when left on board an automated analyser. during the investigation, it was determined that when the r2 reagent is exposed to the atmosphere for prolonged periods of time, on board an automated analyser, crystals may form. sekisui has identified the crystals form from a standard component of the reagent. the amount of time to crystalise is dependent on reagent usage, temperature, and length of time on board the analyser. abbott internal testing has shown that the crystal formation does not impact architect csystem instrument performance.
  • 조치
    Abbott is advising users to only leave the reagent on board the analyser for a maximum of 8 days and has decreased the calibration interval to 24 hours. Additionally, Abbott is reducing the shelf life for all affected batches to nine (9) months. Any reagent with an expiry date of 09-2016 should be discarded and the expiry dates for other affected batches amended. Abbott is advising users there is no requirement to review previously generated results. This action has been closed-out on 03/02/2017.

Device

Acetaminophen (Paracetamol) Reagent (used with L3K Assay in conjunction with the Architect cSyste...
  • 모델명 / 제조번호(시리얼번호)
    Acetaminophen (Paracetamol) Reagent (used with L3K Assay in conjunction with the Architect cSystem Analyser). An in vitro diagnostic medical device (IVD)Sekisui List Numbers: 506-10 and 506-30Abbott List Number: 3R11-20Multiple lot numbers and expiry datesARTG Number: 224545
  • 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