Events

Kit de confirm HBs Ag 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Ortho-Clinical Diagnostics 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
    2005-12-26
  • 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-du-dmdiv-kit-de-confirmation-ag-hbs-ortho-clinical-diagnostics
  • 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
    On 23/12/2005, Ortho-Clinical Diagnostics withdrew from the market the batch 240 (03/04/2006) and 250 (03/07/2006) of the in vitro diagnostic medical device called Kit de confirm HBs Ag reference 822 8595. This device is used to confirm the presence of hepatitis B virus surface antigen (HBsAg) in human serum and plasma samples (EDTA, heparin or citrate ) found to be repeatable with the Vitros Ag HBs test. This is due to the fact that the sample diluent produces a higher background that may lead to unconfirmed (false negative for HBsAg) results for samples with has given positive results with the Vitros HBs Ag test. This risk concerns only previously diluted samples, that is to say, samples that have obtained a Vitros HBs Ag positive test result> 500 S / C. The company has directly notified the recipients of the offending batches by means of the enclosed message (26/12/2005) (101 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Kit de confirm HBs Ag

Manufacturer

Ortho-Clinical Diagnostics