Events

Device Recall Benchmark & Discovery 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ventana Medical Systems 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
    49516
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2118-2013
  • 사례 시작날짜
    2008-06-12
  • 사례 출판 날짜
    2013-08-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73710
  • 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
    Slide stainer, automated - Product Code KPA
  • 원인
    Ventana medical system is initiating the recall of the benchmark and discovery series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.
  • 조치
    Ventana sent an Urgent Medical Device Correction Notification letter dated June 16, 2008 to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter instructed customers to carefully read and perform all of the actions outlined in the notification letter concerning potential safety issue. Customers with concerns regarding the staining results on any patient specimen are instructed to follow their internal Quality Procedures regarding the review of patient reports. For question contact your local Customer Service Center.

Device

Device Recall Benchmark & Discovery
  • 모델명 / 제조번호(시리얼번호)
    BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.
  • 제품 설명
    Benchmark XT/LT and Discovery XT || Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. || Product Usage: Usage: || The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • 제조사 주소
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755
  • 제조사 모회사 (2017)
    Roche Holding Ag
  • Source
    USFDA