Events

BD 79b (SN8) phycoerythrin (PE) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton, Dickinson and Company, BD Biosciences 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
    75250
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0128-2017
  • 사례 시작날짜
    2016-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149794
  • 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
    Reagents,specific,analyte - Product Code MVU
  • 원인
    Cd79b (sn8) pe is contaminated with a fitc conjugate of unknown antigenic specificity.
  • 조치
    BD Life Sciences sent an Urgent Product recall letter dated September 2016 on September 21, 2016 ,to all affected customers via UPS and/or e-mail. Customers were instructed to inspect their inventory to determine if they have any of the affected lots and to discard the affected lots, and BD will issue replacement product. Customers were also instructed to complete the attached Customer Response Form whether or not they have any affected product. Customers needing further assistance should contact BD Customer Support at 855-236-2772 (prompt 3). For customers outside the US, contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6307.

Device

BD 79b (SN8) phycoerythrin (PE)
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 5348570; Expiration Date: 31 July 2017
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to CA, MN, OH and TX.
  • 제품 설명
    CD79b PE (ASR) , Catalog number 335816 ; || Hematology: || The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. || antigen
  • Manufacturer
    Becton, Dickinson and Company, BD Biosciences

Manufacturer

Becton, Dickinson and Company, BD Biosciences
  • 제조사 주소
    Becton, Dickinson and Company, BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1812
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA