Events

Device Recall Cell Marque CD7 (MRQ12); 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
    61055
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1176-2012
  • 사례 시작날짜
    2012-01-23
  • 사례 출판 날짜
    2012-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107190
  • 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
    Letter received from supplier that material received in october 2009 was labeled as cd7, but was actually cd 2.
  • 조치
    Cell Marque sent a Field Notification letter dated January 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and return the attached form indicating they have received the notification. Customers were also asked to destroy any existing inventory of the affected product. If the product was shipped to their customers, customers should confirm that they have contacted those customers. Customers were asked to complete, sign and date and return the attached Acknowledgement Form by faxing it to 1-916-746-8989 or by scanning it and emailing it to bdevos@cellmarque.com. For questions regarding this recall call 1-800-665-7284 or 1-916-746-8900. .

Device

Device Recall Cell Marque CD7 (MRQ12);
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers: 107M-14 (0.1 ml concentrate); 107M-15 (0.5 ml concentrate); 107M-16 (1.0 ml concentrate); 107M-17 - (1.0 ml predilute) and 107M-18 (7.0 ml predilute). Product lot # 8109, Exp 2012-09.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Greece, Turkey, Italy, The Netherlands, Spain, Portugal, France, Israel, S. Korea, Pakistan, Morocco, Russia and Brazil.
  • 제품 설명
    Cell Marque CD7 (MRQ-12); || Mouse Monoclonal Antibody, || Antibody is bottle in HDPE bottle with screw cap lid with container label. Then put in cardboard Box with outer box label. || Cell Marque, Rocklin, CA 95677, || intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in section of formalin fixed, paraffin embedded tissue section 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 or physician.
  • Manufacturer
    Cell Marque Corporation

Manufacturer

Cell Marque Corporation
  • 제조사 주소
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • 제조사 모회사 (2017)
    Sigma-Aldrich Co. Llc
  • Source
    USFDA