Events

Device Recall CD99 (H0361.1) Mouse Monoclonal Antibody. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cell Marque 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
    59436
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-3110-2011
  • 사례 시작날짜
    2011-07-12
  • 사례 출판 날짜
    2011-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102783
  • 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
    Incorrect label on product bottle, although labeling on outer box is correct.
  • 조치
    The firm, Cell Marque, notified customers by telephone on July 12, 2011. The customers were instructed to return the product. Cell Marque immediately issued replacement of the product. If you have any further question or require additional documentation, contact the VP of Regulatory and Quality Affairs at (916) 746-8900.

Device

Device Recall CD99 (H0361.1) Mouse Monoclonal Antibody.
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 1113202A, Exp date: 2014-04.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.
  • 제품 설명
    Cell Marque antibody CD99 (H036-1.1) || Mouse Monoclonal Antibody. || Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 || The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.
  • Manufacturer
    Cell Marque Corporation

Manufacturer

Cell Marque Corporation
  • 제조사 주소
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677
  • 제조사 모회사 (2017)
    Sigma-Aldrich Co. Llc
  • Source
    USFDA