Events

Device Recall UltraVision Plus Detection System, AntiPolyvalent, AlkPhos/Fast Red (Ready to Use) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Lab Vision Corporation 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
  • 사례 ID
    60967
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1085-2012
  • 사례 시작날짜
    2012-01-11
  • 사례 출판 날짜
    2012-02-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106999
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Immunohistochemistry reagents and kits - Product Code NJT
  • 원인
    Firm was notified by vendor that a component in kits was not meeting internal specifications. declination in product performance confirmed by thermo fisher.
  • 조치
    Lab Vision Corporation of Thermo Fisher Scientific sent a Product Recall Notification letters dated January 11, 2012 to all affected customers. The letter identified the affected products, reason for recall and necessary actions to be taken. Customers were instructed to examine inventory, discontinue use, destroy any remaining inventory, follow normal procedure to order an alternate lot of the affected products, retain a copy of this letter for their laboratory records, if the affected products were further distributed provide a copy of this letter to them and complete the attached Customer Recall Response Form and return within 5 days. For questions regarding this information, U.S. customers should call Technical Support at 510-771-1595. Customers outside the U.S. should contact their local area Customer Service.

Device

Device Recall UltraVision Plus Detection System, AntiPolyvalent, AlkPhos/Fast Red (Ready to Use)
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: TP-015-AFX; Lot Number: AFX1104027, Exp. 6/2012; Lot Number: AFX110705, Exp 8/2012. .
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.
  • 제품 설명
    UltraVision Plus Detection System; || Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use) || Manufactured by: Lab Vision Corporation || 46360 Fremont Blvd, Fremont, CA 94538 || Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
  • Manufacturer
    Lab Vision Corporation

Manufacturer

Lab Vision Corporation
  • 제조사 주소
    Lab Vision Corporation, 46360 Fremont Blvd, Fremont CA 94538-6406
  • Source
    USFDA