Events

Device Recall Capillary Caps for RAPIDLyte Multicap and MulticapS Blood Collection Capillaries 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
    70287
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1256-2015
  • 사례 시작날짜
    2015-01-22
  • 사례 출판 날짜
    2015-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133254
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • 원인
    Capillary caps for rapidlyte multicap and multicap-s blood collection capillaries may not attach and result in breakage of the glass capillary.
  • 조치
    Siemens Healthcare issued an Urgent Field Safety Notice via e-mail to affected Siemens Healthcare Diagnostics Regional offices on January 22, 2015 both in the United States and elsewhere for communication with affected customers. Siemens advises customers to use caution when applying the Capillary Caps with Siemens Multicap glass and Multicap-S plastic capillaries to minimize the potential for breakage or bending.

Device

Device Recall Capillary Caps for RAPIDLyte Multicap and MulticapS Blood Collection Capillaries
  • 모델명 / 제조번호(시리얼번호)
    All lot codes
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. US Nationwide, Australia, Austria, Belgium, Bosnia, Herzegovina, Canada, Colombia, Croatia, Curacao, Czech Republic, Estonia, Finland, France, Georgia, Germany, Great Britain, Hong Kong, Ireland, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates.
  • 제품 설명
    Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 || For use with blood collection Multicap glass and Multicap-S plastic capillaries || SMN: 10328655 || Legacy Part number: 478527
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • 제조사 주소
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Drive, Norwood MA 02062
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA