Events

Reagents for analyzers modular immunochemical and biochemical ARCHITECT: reagent kit ARCHITECT T3 General / ARCHITECT Total T3 Reagent Kit (Lot: 38901UI00, 38901UI01) 를 위한 리콜 또는 안전성 경고

Ministry of Health of the Republic of Belarus에 따르면, 해당 리콜 또는 안전성 경고 는 Belarus 에서 Diagnostics Division, Ireland 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Safety alert
  • 사례 연번
    ИМ-7.97735
  • 날짜
    2014-09-23
  • 사례 국가
    Belarus
  • 사례 출처
    MHRB
  • 사례 출처 URL
    https://www.rceth.by/ru/Safety/MedSafety
  • 비고 / 경고
    Belarussian data is current through June 2016. 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 Belarus.
  • 데이터 추가 비고
  • 원인
    Abbott decided to report the recall of the architect total t3 reagent kit (lot: 38901ui00, 38901ui01), and provide instructions on the actions that should be taken. the company has determined that 17% of the reagents of the two lots listed above may show lower relative light units (rlu) than expected, which in turn may affect the results of patient analyzes and make the indicators higher than expected. if you use or have reagent kits from lots 38901ui00 or 38901ui01, you should: stop using and destroy all remaining reagent kits according to your laboratory procedures; review previously obtained patient test results.

Device

Reagents for analyzers modular immunochemical and biochemical ARCHITECT: reagent kit ARCHITECT T3...

Manufacturer

Diagnostics Division, Ireland
  • 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
    MHRB