Events

Rapid Neg BP Combo Panel Type 3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, 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
    69540
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0170-2015
  • 사례 시작날짜
    2014-10-17
  • 사례 출판 날짜
    2014-11-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130889
  • 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 increase in false positive susceptible results on rapid neg bp combo panel type 3 and rapid neg urine combo panel type 1 used with microscan microbiology systems.
  • 조치
    Customer Recall notification letters were sent on October 17, 2014. Letters recommend that any remaining inventory be discarded and that consideration be given to reviewing previous test result, conduct patient follow up and/or repeat testing if isolates are still available. A second letter clarifying the recall was issued November 7, 2014 which provided additional information as requested by CDRH.

Device

Rapid Neg BP Combo Panel Type 3
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: B1017-117, Siemens Material number 1044632, lot numbers: 2014-12-10, Exp. 2014-12-10; 2015-02-27, Exp 2015-02-27; 2015-06-23, Exp 2015-06-23.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.
  • 제품 설명
    Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. || MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA