TRUEtrack and TRUEtest Blood Glucose Test Strips 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Trividia Health 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
    2016-07-20
  • 사례 출판 날짜
    2016-07-20
  • 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: truetrack and truetest blood glucose test strips the health canada has posted a medical device safety alert concerning the truetrack and truetest blood glucose test strips, manufactured by trividia health, inc. the model and lot numbers affected by this issue are described below: truetrack blood glucose test strips [model number: a3i20-80, a3i20-81; lot number: rs4567ica, rs4704ica] truetest blood glucose test strips [model number: e3i20-80, e3i20-81; lot number: ps2284ica, ps2316ica, ps2335ica] a limited number of sealed test strip vial boxes from certain blood glucose test strip lots may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can affect strip performance. in particular, test strips exposed to the environment may provide incorrect low blood glucose results. according to the manufacturer, inaccurate low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment. for details, please refer to the health canada’s websites: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59384r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 july 2016.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: TRUEtrack and TRUEtest Blood Glucose Test Strips
  • Manufacturer

Manufacturer