Events

Monolisa AntiHBs EIA and Monolisa AntiHBs Calibrator Kit 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
    49126
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1620-2010
  • 사례 시작날짜
    2008-08-11
  • 사례 출판 날짜
    2010-05-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-05-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72844
  • 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
    Hepatitis B Test - Product Code LOM
  • 원인
    The package insert provided with this kit contains a typographical error, giving incorrect directions to prepare a working conjugate solution. if these directions are followed, it would result in a 1:6 dilution and invalidate the assay.
  • 조치
    All domestic customers were notified via an Urgent Product Correction customer letter sent by DHL or FedEx on 8/11/08. Enclosed with the letter was a corrected package insert. The Canadian subsidiary was notified via e-mail on 8/11/08. The letter advised customers of the correct wording, and advised that a new corrected package insert was enclosed and to make note of the correction in the laboratory procedures. Questions should be directed to Bio-Rad Laboratories Technical Support at 1-800-224-6723.

Device

Monolisa AntiHBs EIA and Monolisa AntiHBs Calibrator Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot #'s: 288BEE and 056CEE
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; || MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" || For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.
  • 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