Events

PHENOPLAC RH-KELL device 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 DIAGAST 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
    2003-02-11
  • 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-dispositifs-phenoplac-de-la-societe-diagast
  • 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
    The company DIAGAST asks the holders of the lots. 108000 (per.02.03) to 114000 (per.11.03) of the in vitro diagnostic medical device called PHENOPLAC TOTAL - ref. 79713/79724. 108000 (per.02.03) to 111000 (per.09.03) of the PHENOPLAC RH-KELL device - ref. 79710/79725. 106000 (per.02.03) and 107000 (per.06.03) of the device PHENOPLAC STANDARD - ref.79712 / 79725. 103000 (per.07.03) of the PHENOPLAC 16 RH-KELL device - ref. 79716. not to use them any more and to destroy them as soon as you receive lots 115000 (per.12.03) of the device PHENOPLAC TOTAL - ref. 79724 and 112000 (per.12.03) of the device PHENOPLAC RH-KELL - ref.79730 .. This measurement is consecutive to a modification of the packaging of each microplate of the boxes guaranteeing the reactivity of the anti-e (RH5) antibody / MS16 clones + MS63 present in these plates and consequently, leading to the suppression of the systematic control, with another reagent, results "e" (RH5) negative; this measure avoids any confusion of use related to the coexistence of two techniques for the same reference.

Device

PHENOPLAC RH-KELL device
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    DIAGAST

Manufacturer

DIAGAST