AU480 Chemistry Analyzer 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Beckman Coulter 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2015-09-29
  • 사례 출판 날짜
    2015-09-29
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: beckman coulter au480 chemistry analyzer medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its au480 chemistry analyzer [software version 1.81]. a software defect has been identified on newly installed au480 systems with software version 1.81. the defect may generate incorrect test results for 2 step method assays on au480 systems configured with closed channels. new au480 systems configured to allow for full open channels are not affected. the software defect occurs when edit and then confirm are pressed on the specific test parameters screen of closed channels. the result is the measuring point-2 settings will be deleted. the measuring point 2 settings are used for sample blank adjustments for 2 step methods. for samples which may have lih (lipemia, icterus, hemolysis) or other interferant, there is a potential for false high results to be calculated for 2 step method assays on closed channels. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 september 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Beckman Coulter AU480 Chemistry Analyzer
  • Manufacturer

Manufacturer