Events

Device Recall IMMULITE/IMMULITE 1000 Rubella IgM 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
    75037
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0081-2017
  • 사례 시작날짜
    2016-08-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149151
  • 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
    Enzyme linked immunoabsorbent assay, rubella - Product Code LFX
  • 원인
    Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of rubella igm assay on the immmulite 2000/immulite 2000 xpi platforms.
  • 조치
    Siemens sent an Urgent Medical Device Recall Letter IMC16-20.A.US , dated August 24, 2016, to the US consignees via FedEx, and an Urgent Field Safety Notice IMC16-20.A.OUS (dated August 2016) was sent to foreign representatives for distribution to foreign consignees. Customers were instructed to discontinue use of and discard the affected kit lots. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For questions, customers were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative.

Device

Device Recall IMMULITE/IMMULITE 1000 Rubella IgM
  • 모델명 / 제조번호(시리얼번호)
    Kit lots 0333 and 0334 (OUS)
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries: Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab Emirates, and Uruguay.
  • 제품 설명
    SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- || For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA