Events

Device Recall Rubella IgG EIA test 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
    49449
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0908-2010
  • 사례 시작날짜
    2008-08-20
  • 사례 출판 날짜
    2010-03-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-04-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73408
  • 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
    Elevated optical density (od) values with the kit negative control.
  • 조치
    An "Urgent Product Correction" letter dated August 26, 2008 was sent via overnight carrier to all customers. The letter described the affected product, problem, and action to be taken by customer. The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed. The remaining kits will be replaced once the form is completed and faxed. If you have any questions, please contact Technical Support at 1-800-224-6723, options 2 then 4.

Device

Device Recall Rubella IgG EIA test kit
  • 모델명 / 제조번호(시리얼번호)
    Lot F1108
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC
  • 제품 설명
    Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 || For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.
  • 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