Events

Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 International Technidyne Corp. 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
    54768
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0893-2011
  • 사례 시작날짜
    2010-03-31
  • 사례 출판 날짜
    2011-03-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89130
  • 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
    Upc Reader (bar code reader) - Product Code RFZ
  • 원인
    There is a mismatch between the class of the laser barcode scanner and the labeling of the hemochron signature elite: some of the devices were inadvertently equipped with class ii laser barcode scanner instead of the intended class i barcode scanner.
  • 조치
    Urgent - Medical Device Recall - Hemochron Signature Elite letters, dated February 24, 2010, by Federal Express to all direct customers. The letter informed customers of the issue and stated that the problem does not negatively affect the performance of the product and to continue using the product as intended. In addition, customers are to notify the appropriate personnel about the notice, complete and return the attached form, and an ITC representative will contact customers to discuss arrangements to re-label their devices. Customers can contact ITC Technical Support at 800-579-2255 (US) or 732-548-5700 ext 4700 (International) if they have any questions regarding this issue and notice. Customers can also email sigelitescan@itcmed.com with questions.

Device

Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers SE2830 to SE2854 (inclusive); SE2880 to SE4789 (inclusive); SE0260, SE0366, SE0567, SE0764, SE0843, SE0970, SE1086, SE1198, SE1208, SE1212, SE1438, SE1456, SE1580, SE1711, SE2029, SE2136, SE2602, and SE2618.
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.
  • 제품 설명
    Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. || The system is intended to be used only with test cuvettes that are available from ITC.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • 제조사 주소
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA