Events

BD FocalPoint" 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Tripath Imaging, Inc. 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
    61444
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1630-2012
  • 사례 시작날짜
    2011-10-06
  • 사례 출판 날짜
    2012-05-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108113
  • 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
    Processor, cervical cytology slide, automated - Product Code MKQ
  • 원인
    The cable tie mounts that adhere to the inside of the focalpoint do not adhere as intended and can therefore become detached.
  • 조치
    BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit. For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions. For questions regarding this recall call 918-563-1624.

Device

BD FocalPoint"
  • 모델명 / 제조번호(시리얼번호)
    To be obtained
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
  • 제품 설명
    BD Focal Point"230V LC (Refurbished), Catalog number: 490681. || The BD Focal Point" Slide Profiler (formerly the AutoPap¿¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
  • Manufacturer
    Tripath Imaging, Inc.

Manufacturer

Tripath Imaging, Inc.
  • 제조사 주소
    Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA