Events

Architect / Folates-Controls;Architect / Folates-Thinner Manual 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 ABBOTT DIAGNOSTIC 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
  • 날짜
    2003-12-19
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-2-dmdiv-architect-folates-par-abbott-diagnostic
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    Abbott Diagnostic is withdrawing from the market. batches 94718M200 (per.31.01.04) and 04619M100 (per.28.06.04) of the in vitro diagnostic medical device called Architect / Folates-Controls - reference 6C12-1. and batches 07460M300 (per.18.06.04) and 11435M100 (per.08.09.04) of the in vitro diagnostic medical device known as Architect / Folates-Thinner Manual - reference 6C12-5. due to a lack of stability of human serum albumin in their composition; this defect may lead to lower than expected test results and lower than expected patient results for diluted samples only. Abbott Diagnostic informs affected users of the presence of the diluent in batch kits 06537M100; 09888M100; 06537M101; 05081M100; 07465M300 and 10587M200 of the in vitro diagnostic medical device called Architect / Folates Reagents - references 6C12-20; 6C12-25 and 6C12-30 and asks them, as a precaution, to no longer use the protocol "automatic dilution" with these lots .. These devices are intended for the determination of folate in serum, plasma and human erythrocytes on the Architect automaton. The results of this assay should be used in conjunction with other available data such as the results of other biological analyzes and clinical data.

Device

Architect / Folates-Controls;Architect / Folates-Thinner Manual
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    ABBOTT DIAGNOSTIC

Manufacturer

ABBOTT DIAGNOSTIC
  • 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
    LAANSM