Events

Device Recall MicroScan Neg Breakpoint Combo 34 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter, Inc. 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
    70874
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1522-2015
  • 사례 시작날짜
    2014-05-14
  • 사례 출판 날짜
    2015-04-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135379
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • 원인
    Siemens healthcare diagnostics has received complaints regarding panel degradation with a portion of the microscan neg breakpoint combo 34 (nbp34) panel lot 2014-05-28.
  • 조치
    Siemens sent an Urgent Medical Device Recall letter dated May 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The risk to health is explained and users are asked to discontinue use and discard any of the recalled lot still in inventory. No other lot numbers of the NBPC 34 panels are affected and may still be used. The Field Correction Effectiveness Check form should have been completed and returned to Siemens. PLEASE FAX THIS COMPLETED FORM TO 302-631-8467. Contact Siemens Customer Care Center or local Siemens Tech support. For further questions please call (916) 374-3031

Device

Device Recall MicroScan Neg Breakpoint Combo 34
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number B1017-404, lot # 2014-05-28, Expiry 2014-05-28.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.
  • 제품 설명
    MicroScan -Neg Breakpoint Combo Panel Type 34; || Catalog number B1017-404; Panel || MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to || No.1 the species level of colonies, grown 34 on solid media, of rapidly growing || aerobic and facultative anaerobic gram-positive bacteria
  • Manufacturer
    Beckman Coulter, Inc.

Manufacturer

Beckman Coulter, Inc.
  • 제조사 주소
    Beckman Coulter, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA