Events

AlleleSEQR HLA - from QARAD 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 ATRIA 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
    2004-11-26
  • 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-atria-alleleseqr-hla-de-la-societe-qarad
  • 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
    QARAD (manufacturer ATRIA) withdraws from the market batches of the following in vitro diagnostic medical devices:. ATRIA SEQR Allele HLA-A SBT - lot A520H04 (per 13/11/05) ATRIA SEQR Allele HLA-B SBT - lot B517H04 (per 13/11/05 ATRIA Allele SEQR HLA-C SBT - lot C520H04 (per 13 / 11/05 ATRIA SEQR Allele DRB1 SBT - lot R51J04 (per 13/11/05) ATRIA SEQR Allele DQB1 SBT-lot Q59J04 (per 13/11/05 ATRIA Allele SEQR DPB1 SBT- lot P59J04 (per 13/11 / 05), following the demonstration of a decrease in the stability time: the actual expiry dates of the DNA sequencing reaction mixtures contained in these product kits are earlier than those indicated on the product labels. The company has directly notified the recipients of the lots concerned by means of the attached message (26/11/2004) (61 KB) Letter from Atria (26/11/2004) (61 KB)

Device

AlleleSEQR HLA - from QARAD
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    ATRIA

Manufacturer

ATRIA
  • Source
    LAANSM