Events

Membrane box for electrode E 1001 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 RADIOMETER 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
    2002-03-06
  • 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-membranes-pour-electrodes-e-1001-analyseurs-abl-serie-700-de-radiometer2
  • 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
    (Cancels and replaces the mail of 28/02/2002: because other batches than those previously mentioned are concerned by this withdrawal, however the message addressed to the users remains identical .. The company RADIOMETER withdraws from the market all the batches lower than the lot R0080 (expiry date 12/2003) of the in vitro diagnostic medical device called membrane box for electrode E 1001 - code 942-058 reference D711 (accessories of analyzers ABL series 700) .. Application range: accessories of analyzers ABL 700 series (blood gas and electrolyte analyzers) .. analyzers used for emergency tests Description of the defect: possible absence, in some membranes, of the layer of cellophane which is in contact with the sample and which facilitates the elimination, by rinsing, after the test Risk of minor analytical bias on the parameters pH, Na, K, Ca, Cl at a high analytical rate (more than 50 analyzes per day).

Device

Membrane box for electrode E 1001
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    RADIOMETER

Manufacturer

RADIOMETER
  • Source
    LAANSM