Events

Microscan Neg Breakpoint Combo 47, B1017417 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
    70893
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1529-2015
  • 사례 시작날짜
    2014-08-08
  • 사례 출판 날짜
    2015-04-27
  • 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=135434
  • 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
    Technical support bulletin issued in february 2013 did not mention performance limitation for proteus mirabilis and imp when using the clsim100-s20 revised interpretive criteria.
  • 조치
    The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated August 7, 2014 to affected customers by trackable method. The letter describe product, problem and actions to be taken. The customers were instructed to confirm receipt of the letter; complete the attached "Field Correction Effectiveness Check" form via fax to Siemens Healthcare Diagnostics at 302-631-8467;TSB 190 has been removed from use and archived from the Siemens Document Library, if you have a hardcopy, discard it appropriately;and follow the listed in instructions and retain and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center; Quality Systems & Compliance Director at 916-374-3031 or email: juntalan@beckman.com or your local Siemens technical support representative.

Device

Microscan Neg Breakpoint Combo 47, B1017417
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: B1017-417; Siemens Material Number (SMN): 10483099.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) and to countries of: Argentina, Bahamas, Brazil, Canada, China, Ecuador, Egypt, Germany, Lithuania, Mexico, Paraguay, Peru Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Uruguay, and Venezuela.
  • 제품 설명
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels || Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 || Breakpoints || Panel: Neg/BP Combo 47, Catalog B1017-417 || Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed || for use in determining antimicrobial agent susceptibility and/or identification to the || species level of aerobic and facultatively anaerobic gram-negative bacilli.
  • 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