Events

IMMAGE BUFFER 1 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BECKMAN COULTER 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
    2002-10-14
  • 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-reactif-immage-buffer-1-reference-447650-de-la-societe-beckman-coulter
  • 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
    BECKMAN COULTER withdraws from the market batches T111211 (expiry date 30/11/03), T202122 (expiry date 29/02/04), T202211 (expiry date 29/02/04) and T204184 (expiry date 30/04/04) of the reagent called IMMAGE BUFFER 1 / reference 447650 following a drift of quality controls during the use thereof, this drift being due to the instability of one of the components used in the manufacture of this reagent .. This reagent is used for the determination of specific proteins (see list) on the IMMAGE automaton. List of proteins. A1M Alpha 1 microglobulin. AAG Orosomucoid or Alpha 1 glycoprotein acid. AATAlpha 1 antitrypsin. ALB Albumin. AMG Alpha 2 macroglobulin. APA Apolipoprotein A. APB Apolipoprotein. AT3 Antithrombin II. B2MX Beta 2 microglobulin. C3 Complement C. C4 Complement C. CER Ceruloplasmin. HPT Haptoglobin. IGA Immunoglobulin A (IGALC IGALC IgG immunoglobulin A low concentration IgG immunoglobulin G (IgG IgM immunoglobulin M (IgM IgMLC immunoglobulin M low concentration IGU immunoglobulin G urinair KAP light chains kapp LAM light chains lambda LPAX lipoprotein ( A. MA Microalbumin, PAB Prealbumin, PFB Properdine Factor, TRF Transferrin, TRU Urinary Transferrin

Device

IMMAGE BUFFER 1
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER