Events

Device Recall Clinitek 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bayer HealthCare LLC, Diagnostics Div 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
    26312
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0911-03
  • 사례 시작날짜
    2003-06-19
  • 사례 출판 날짜
    2003-06-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27494
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    Analyzer will produce erroneous results due to missing grounding strap.
  • 조치
    Marketing sent a 'dear customer' letter to each account on May 13, 2003 telling them that their instrument had been identified as not meeting a production specification. An urgent product correction letter was subsequently sent to each account on or about June 20, 2003. The analyzers affected will be replaced.

Device

Device Recall Clinitek
  • 모델명 / 제조번호(시리얼번호)
    serial numbers 168252 through 169574.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 유통
    United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
  • 제품 설명
    Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed.]
  • Manufacturer
    Bayer HealthCare LLC, Diagnostics Div

Manufacturer

Bayer HealthCare LLC, Diagnostics Div
  • 제조사 주소
    Bayer HealthCare LLC, Diagnostics Div, 1884 Miles Ave., Elkhart IN 46515
  • Source
    USFDA