Events

BBL" OXACILLIN SCREEN 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
    58906
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2608-2011
  • 사례 시작날짜
    2011-04-20
  • 사례 출판 날짜
    2011-06-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100500
  • 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, mueller hinton agar/broth - Product Code JTZ
  • 원인
    Oxacillin screen agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.
  • 조치
    BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated April 2011 to all affected customers. The letter identifies the product, problem and actions to be taken by the customers. The letter instructed customers to discontinue use of the affected lot number and discard any remaining packages. Customers were requested to complete and return an attached response form via fax at 410-316-4258. The letter states that all discarded product will be replaced. Questions concerning the recall process were directed to BD Customer Service Department at 1-800-675-0908.

Device

BBL" OXACILLIN SCREEN AGAR
  • 모델명 / 제조번호(시리얼번호)
    Lot 1034119 Exp. 2011/05/03
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Canada, Columbia, Jamaica, South Korea, and Taiwan.
  • 제품 설명
    BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. || Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.
  • 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