Events

AxSYM DMDIV and IMx / Folates 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
    2004-01-08
  • 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-dmdiv-axsym-et-imx-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 withdraws from the market the following batches of in vitro diagnostic medical devices called:. AxSYM / Folate. Specific thinner - reference 3C81-5. lot 05920M200 (per.21.04.04). Erythrocyte Protein Diluent - reference 3C81-6. lot 06783M100 (per.16.02.04). Medium Control - reference 3C81-1. lot 01552M100 (per.17.01.04). IMx / Folate. Medium Control - reference 2220-1. lot 06320M200 (per.10.04.04). Calibrator Mode 1 - reference 2220-4. lot 06371M200 (per.21.05.04). Specific thinner - reference 2220-5. lot 03234M300 (per.11.04.04). Controls Low and High Folate - reference 9C13-1. lots 95523M200 (per.06.03.04) and 08899M100 (per.23.08.04); due to a lack of stability of human serum albumin in their composition; this defect may lead to lower than standard test results and patient results lower than expected only for diluted samples. These devices are intended for the determination of folates in serum, plasma and human erythrocytes on the AxSYM and IMx PLCs. 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

AxSYM DMDIV and IMx / Folates
  • 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