Events

Device Recall BD Tritest CD3 FITC/CD PE/CD45 PerCP (IVD) 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
    74788
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2378-2016
  • 사례 시작날짜
    2016-07-18
  • 사례 출판 날짜
    2016-08-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148462
  • 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
    Counter, differential cell - Product Code GKZ
  • 원인
    Internal review found that some vials of cd3/cd4/cd45 state that the product contains gelatin. the product does not contain gelatin and should state in buffer.
  • 조치
    BD Life Sciences sent an Urgent Product notification letter dated July 18, 2016 to all affected customers via UPS and/or e-mail. The letter informed the user of the issue and states that no action is required since product performance is not impacted. The response form is to be returned to BD as instructed. Customers requiring further assistance were instructed to contact BD Customer Support at 855-236-2772. For questions regarding this recall call 408-954-6080.

Device

Device Recall BD Tritest CD3 FITC/CD PE/CD45 PerCP (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 340383; lot No. Expiration Date 49983, 31 July 2016; 01810, 30 September 2016; 82527, 30 September 2016; 54689 , 30 November 2016; 36715 , 31 December 2016; 15614, 31 January 2017; 57797, 28 February 2017.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA
  • 제품 설명
    BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); || Catalog number 340383. || Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. || Hematology: || BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte || subsets in erythrocyte-lysed whole blood.
  • 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