Events

Device Recall BBL TM LYSINE IRON AGAR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Co. 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
    61006
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1109-2012
  • 사례 시작날짜
    2012-01-11
  • 사례 출판 날짜
    2012-02-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107174
  • 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
    Culture media, antimicrobial susceptibility test - Product Code LKA
  • 원인
    Lysine iron agar may not produce the correct biochemical reactions with quality control organisms over the shelf life of the product.
  • 조치
    BD Diagnostics Systems sent an "URGENT PRODUCT RECALL" letter dated January 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard any remaining packages. A form was attached for customers to complete and return via fax to: Attention: Regulatory Compliance at 410-316-4258. Contact the BD Technical Services Department at 1-800-638-8663 for questions regarding this recall.

Device

Device Recall BBL TM LYSINE IRON AGAR
  • 모델명 / 제조번호(시리얼번호)
    Lot number 0238264 Exp. 3/31/14
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TX, VA, and WI, and the countries of Belgium, Canada, Chile, China, Columbia, Costa Rica, Mexico, El Salvador, Ecuador, Japan, Manila, Singapore, Peru, Taiwan, and Venezuela.
  • 제품 설명
    BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton, Dickinson and Company, Sparks, MD 21152 USA 38800 Le Pont de Claix, France. || Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • 제조사 주소
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA