Events

Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box. 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
    32943
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1458-05
  • 사례 시작날짜
    2005-07-28
  • 사례 출판 날짜
    2005-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-10-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41123
  • 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
    Microbiological media for antibiotic susceptibility testing gives false test results.
  • 조치
    The recalling firm notified distributors and direct accounts by fax, e-mail, and letters on 07/28/2005. The notifications advised of false resistant results with control organisms known to be oxcacillin susceptible. Customers were instructed to discontinue use of the lot and discard for replacement. Distributors were requested to discontinue distribution and provide consignee list for subsequent notification. Response forms are included with the recall letters.

Device

Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 1...
  • 모델명 / 제조번호(시리얼번호)
    Lot #5140549, EXP 8/17/05
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was sold to distributors and direct account end-users worldwide including government facilities.
  • 제품 설명
    Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.