Events

Device Recall BD FMC7 FITC 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
    73155
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0851-2016
  • 사례 시작날짜
    2016-01-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143258
  • 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
    Becton, dickinson and company (bd) has determined that the fmc7 fitc (asr) has an incorrect expiration date listed on the vial label.
  • 조치
    BD Biosciences sent an Urgent Medical Device Recall letters dated January 2016 via certified mail to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that the remaining stock of the product can be used until 6-30-16. however, if prefer they can discard all remaining stock of the affected lot and BD will replace. The letter request customers complete the Tracking/verification form and returned to BD Biosciences, per the instructions (mail, fax, or email). For questions contact your local BD representative or BD Customer Support at 877-232-8995 (prompt 3,3).

Device

Device Recall BD FMC7 FITC
  • 모델명 / 제조번호(시리얼번호)
    Model number: 340918: Lot number: 5341918. Incorrect expiry date on label 03/31/2017. correct expiry should be 6/30/16.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan.
  • 제품 설명
    BD FMC7 FITC: Model 430918. || FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. || Product Usage: || Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 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