Remel Vibrio cholerae Inaba agglutinating serum 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Thermo Fisher Scientific 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
    2013-06-28
  • 사례 출판 날짜
    2013-06-28
  • 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: thermo fisher scientific remel vibrio cholerae inaba agglutinating serum medical device manufacturer, thermo fisher scientific, has issued a field safety notice concerning remel vibrio cholerae inaba agglutinating serum (model no.: zm06/r30165101 and lot no.: 1155581). according to the manufacturer, an internal technical investigation has confirmed that the performance of vibrio cholerae inaba agglutinating serum lot: 1032772 sold separately as r30165101 lot: 1155581 has deteriorated, and is no longer agglutinating with positive cultures in the slide and tube agglutination test. the manufacturer advises customers who have used the affected lot of vibrio cholerae inaba agglutinating serum to review results reported and consider retesting and/or seek appropriate expert advice as a false negative result may have been obtained. furthermore, the manufacturer requests users to destroy any remaining inventory of the affected vibrio cholerae inaba agglutinating serum and contact customer services or local distributor to request replacement product. according to the manufacturer, the affected products were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 june 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Thermo Fisher Scientific Remel Vibrio cholerae Inaba agglutinating serum
  • Manufacturer

Manufacturer