Events

Device Recall EVOLIS Assay Protocol Files ( APF) Software 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
    56389
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2201-2011
  • 사례 시작날짜
    2010-07-19
  • 사례 출판 날짜
    2011-05-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93387
  • 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
    Enzyme linked immunoabsorbent assay, rubella - Product Code LFX
  • 원인
    The evolis assay protocol files software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.
  • 조치
    Bio-Rad Laboratories sent an Urgent Product Correction letter dated July 19, 2010, to all customer sites via FedEx. There are two issues related to The EVOLIS Assay Protocol Files (APF) Software that could potentially affect patient results. Issue 1 involves quantitative sample test/calculations/results interpretation for assays with linear regression, point to point or 4PL data reduction. Issue 2 involves sample test results with " Result Report Flags''. A software patch to correct these two issues will be sent to each customer site. Bio-Rad Laboratories will work with each customer to complete documentation confirming that the software patch has been successfully installed on each instrument. If you have any questions or concerns regarding these two issues, please contact Technical Support at 1-800-224-6723, option 2 and then option 3.

Device

Device Recall EVOLIS Assay Protocol Files ( APF) Software
  • 모델명 / 제조번호(시리얼번호)
    APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- Including Puerto Rico.
  • 제품 설명
    Software CD is labeled in part: || "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" || The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.
  • 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