Events

ARCHITECT I - 2ND GENERATION TESTOSTERONE REAGENT 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
    94615
  • 사례 위험등급
    III
  • 사례 시작날짜
    2016-03-09
  • 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
    On february 24 2016 a product deficiency was identified. testing performed to investigate complaint ticket 1061060r1715901 (received february 12 2016) confirmed the issue of obtaining the message "no assay" on the architect module display when using the new assay file and testing with architect 2nd generation testosterone reagent kit list number 2p13-28 lot 10458up00. a non-conformance report was opened on 24feb2016. preliminary root cause investigation was performed by tpm axis-shield diagnostics and identified the barcode for this lot was coded with the us assay file number instead of the ous assay file number. the information is hardcoded to the barcode on the microparticle bottle. therefore the customers are unable to test because the ous assay file does not recognize this lot with us assay file. axis shield has both assay files (us and ous) installed on their analyzer which is why the lot passed testing during manufacturing.

Device

ARCHITECT I - 2ND GENERATION TESTOSTERONE REAGENT

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