Events

Device Recall BD Phoenix" Automated Microbiology System ID/AST 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
    57001
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0366-2011
  • 사례 시작날짜
    2010-05-14
  • 사례 출판 날짜
    2010-11-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95158
  • 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
    The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.
  • 조치
    BD Diagnostic Systems issued an "Urgent Product Recall" letter dated May 2010 to direct accounts, identifying the affected product, potential impact, and actions to be taken by the customer. Accounts were requested to respond by returning the enclosed reply form indicating the number of replacements needed for the affected product to be discarded. For assistance iwth replacements, contact BD Customer Service at 800 675-0908. For other inquiries, contact BD Technical Services at 1 800-638-8663.

Device

Device Recall BD Phoenix" Automated Microbiology System ID/AST Panels
  • 모델명 / 제조번호(시리얼번호)
    Lot 0083198 Exp 03/31/2011
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: To direct accounts in CA, MD, NJ, PA. and WI.
  • 제품 설명
    BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***
  • 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