Events

Device Recall Image Upgrade Kit, Catalog 92019C 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bio-Rad Laboratories 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
    66293
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0032-2014
  • 사례 시작날짜
    2013-08-20
  • 사례 출판 날짜
    2013-10-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122026
  • 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
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • 원인
    The fse image upgrade kit (part 92019c) is recalled due to issue related to the export of data from the evolis analyzer to laboratory information systems (lis) when using the monolisa anti-hbs eia quantitative determination in evolis apf version 6.0.
  • 조치
    BioRad has sent an Urgent Product Correction letter dated August 19, 2013, to customers who had the EVOLIS FSE Upgrade Image Kit installed on the EVOLIS at their site by a Bio-Rad Laboratories Field Service Engineer (FSE). This issue impacts laboratory only if you are running the MONOLISA Anti-HBs EIA Quantitative Determination method with EVOLIS APF version 6.0 and TimeLiner Data Management Software. If you use this Quantitative Determination method with EVOLIS APF version 6.0, please contact Bio-Rad Laboratories for additional information or assistance. Bio-Rad Laboratories is currently developing and qualifying a software update CD consisting of the EVOLIS APF V6.0b and Timeliner Data Management Software to correct the issue. The software update CD will be installed by Bio-Rad Field Service Engineers at each of the customer sites when installing the EVOLIS APF V6.0b. Customers should contact Bio-Rad Laboratories at 1-800-224-6723, Option 2 and then Option 3 for any questions about this product correction.

Device

Device Recall Image Upgrade Kit, Catalog 92019C
  • 모델명 / 제조번호(시리얼번호)
    Lot 122822
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
  • 제품 설명
    FSE Image Upgrade Kit, Catalog # 92019C || This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • 제조사 주소
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • 제조사 모회사 (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA