Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents 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
    2017-04-24
  • 사례 출판 날짜
    2017-04-24
  • 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 synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents [reference numbers: 467825 (chol), a60298 (cr-e), a15625 (hdl), a95550 (lact), 445850 (tg and tg-b), 442785 (uric), 378194 (saly); lot numbers: all]. the manufacturer has identified the drugs metamizole (dipyrone), sulfasalazine and sulfapyridine as potential sources of interference when using synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents. with the administration of these drugs, the effects to patient analytes are: metamizole (dipyrone) – may generate false low cholesterol, enzymatic creatinine, hdl cholesterol, lactate, triglycerides and uric acid results. sulfasalazine – may generate false high salicylate results. sulfapyridine – may generate false low salicylate results. information regarding interference with these drugs will be added to the chemistry information sheets (cis) for the respective products. the cis will be updated on the beckman coulter website's technical documents webpage. 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 24 april 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Beckman Coulter Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents
  • Manufacturer

Manufacturer