Events

SECURICARD 1 pocket;SECURICARD 3 bags;PHYSIOCARD 1 pocket;PHYSIOCARD 3 pockets 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 INSTITUT JACQUES BOY 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
    2000-05-19
  • 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-lot-de-reactifs-denommes-securicard-et-physiocard
  • 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
    Lots 064999, 131100, 140700, 170300, 171600, 180700, 224799, 240400, 280900 of the reagent called SECURICARD 1 pocket-reference 109010224; batches 205199, 215199 of the reagent called SECURICARD 3 bags -reference 109010124; batches 240400, 294399 of the reagent called PHYSIOCARD 1 pocket-reference 109012124 and batch 024499 of the reagent called PHYSIOCARD 3 pockets -reference 109012224 of the company INSTITUT JACQUES BOY are withdrawn from the market, following a weakening of the anti-A antibody of these devices (cards) pre-transfusion control, causing a decrease in the intensity of the agglutination reaction leading to a misinterpretation of the test.

Device

SECURICARD 1 pocket;SECURICARD 3 bags;PHYSIOCARD 1 pocket;PHYSIOCARD 3 pockets
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    INSTITUT JACQUES BOY

Manufacturer

INSTITUT JACQUES BOY
  • Source
    LAANSM