Events

Device Recall Difco (TM) Decarboxylase Base Moeller 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
    55697
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1787-2010
  • 사례 시작날짜
    2009-12-09
  • 사례 출판 날짜
    2010-06-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-06-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91593
  • 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, selective and differential - Product Code JSI
  • 원인
    Diagnostic test reagents may not meet quality control specifications.
  • 조치
    The recalling firm notified distributors by letter flagged as "Urgent Product Recall" on 12/09/09. The letter instructed distributors to discontinue distribution and discard product. Distributors were asked to provide customer lists and the recaller subsequently notified the end users to discontinue and discard identified lots for replacement. Customers were asked to return a response form. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall Difco (TM) Decarboxylase Base Moeller
  • 모델명 / 제조번호(시리얼번호)
    Batch No. Exp. Date 9131598 12/13/2013 9055843 12/13/2013
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The product was sold to distributors in the US and to affiliates internationally. A complete list is not currently available.
  • 제품 설명
    Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part ***Becton Dickinson Microbiology Systems, Becton Dickinson, Sparks, MD 21152***
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.