Events

Device Recall BD Phoenix PMIC108 Panels 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
    63737
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0570-2013
  • 사례 시작날짜
    2012-11-06
  • 사례 출판 날짜
    2012-12-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114682
  • 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
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • 원인
    An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
  • 조치
    The firm, BD, sent an "URGENT PRODUCT RECALL" letter dated November 2012 via the telephone and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and discard any remaining packages for replacement and to complete and return the Acknowledgement Receipt Form, whether or not you have any inventory remaining, via fax to: BD Regulatory Compliance at 410-316-4258. BD will issue replacements for the discarded materials. 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 BD Phoenix PMIC108 Panels
  • 모델명 / 제조번호(시리얼번호)
    Lot number 2053373
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
  • 제품 설명
    BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. || The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
  • 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