Events

Device Recall D10 Rack Loader 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bio-Rad Laboratories, 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
    72927
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0695-2016
  • 사례 시작날짜
    2015-12-15
  • 사례 출판 날짜
    2016-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142512
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • 원인
    On a rare occasion, there is a potential to assign a patient result to an incorrect sample id when running in d10 rack loader configuration.
  • 조치
    Urgent Medical Device Correction letters were sent on December 2015 to all affected consignees and subsidiaries. Each subsidiary will be given a Subsidiary Medical Device Correction Notice, Customer Medical Device Correction Notice, and Return Response Form and the number of customers distributed by e-mail. Each Subsidiary much contact customers and translate the Customer Medical Device Correction Notice and Return Response Form as needed. A revised letter to subsidiaries and customers was sent on January 20, 2016.

Device

Device Recall D10 Rack Loader
  • 모델명 / 제조번호(시리얼번호)
    All codes - 2006 to present
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, Belgium, Brazil, Brunei Darussalam, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Malaysia, Maldives, New Zealand, Norway, Austria, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, and UK.
  • 제품 설명
    D-10 Rack Loader; || Model Number 220-0600; || Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis.
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • 제조사 주소
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • 제조사 모회사 (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA