Events

UREA/BUN for Modular system 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Roche 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
    2015-04-09
  • 사례 출판 날짜
    2015-04-09
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150408.html
  • 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: roche urea/bun for modular system medical device manufacturer, roche, has issued a medical device safety alert concerning its urea/ blood urea nitrogen (urea/bun) for modular system. the affected reference numbers are 11729691216, 11929470216, 11929488216, 11929496216, 11929500216 and 11489364216. according to the manufacturer, rounding error occurred during calculation of measuring ranges and technical limits in different units. the error leads wrong measuring ranges and technical limits being stated in the instruction of use and setting in the analyzers. thus, these values have to be corrected as well as harmonized in case where the values stated in the parking insert and setting is not coherent the manufacturer has corrected the measuring range and technical limit for urea/urea nitrogen assay and harmonized in the packing insert as well as in the settings for serum and urine for modular analytics p and d. 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 9 april 2015.

Device

UREA/BUN for Modular system
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Roche UREA/BUN for Modular system
  • Manufacturer
    Roche

Manufacturer

Roche