Device Recall BACTEC(tm) MGIT(tm) 5Tube Spare AST Set Carrier 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
    58480
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2143-2011
  • 사례 시작날짜
    2010-08-31
  • 사례 출판 날짜
    2011-05-05
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-07-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Susceptibility test powers, antimycobacterial - Product Code MJA
  • 원인
    In vitro diagnostic device components are mislabeled.
  • 조치
    BD Diagnostic Systems sent an Urgent Product Recall letter on August 31, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter advised customers to discard any carriers or labels that contain the incorrect barcode for replacement. Accounts were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to 410-316-4258. For questions regarding this recall call BD Customer Service at 1-800-675-0908.

Device

  • 모델명 / 제조번호(시리얼번호)
    not coded
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, MA, MD, VA and the countries of Argentina, Colombia, Belgium, China, India, Hong Kong, Peru, Singapore, Thailand, and Trinidad.
  • 제품 설명
    BACTEC(tm) MGIT(tm) 5-Tube Spare AST Set Carrier, Bag of 3, Catalog 445943. ***Becton, Dickinson and Company || 7 Loveton Circle Sparks, Maryland 21152*** || The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.
  • Manufacturer

Manufacturer

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