Events

BD PrepStain System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bd Diagnostic Systems Tripath 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
    49548
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1090-2009
  • 사례 출판 날짜
    2009-03-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73784
  • 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
    Cervical Cytology Slide Processor - Product Code MKQ
  • 원인
    Software error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.
  • 조치
    BD Diagnostics began contacting known non-gyn customers by phone on 09/26/2008. Customers were notified by Urgent - Important Product Information letter on 09/29/2008. They were advised to stop using the system until they complete a list of actions provided in the letter. A telephone contact number for Technical Support was provided in the letter. A permanent software based solution will be provided to customers when completed. They anticipate the software will be available in October 2008.

Device

BD PrepStain System
  • 모델명 / 제조번호(시리얼번호)
    GYN software version 1.2, Non-GYN version 2.80; GYN software version 1.3.0.1, Non-GYN software version 2.80.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. || PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.
  • Manufacturer
    Bd Diagnostic Systems Tripath

Manufacturer

Bd Diagnostic Systems Tripath
  • 제조사 주소
    Bd Diagnostic Systems Tripath, 4025 Stirrup Creek Dr, Durham NC 27703-9398
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA