Events

VIDAS 3 system 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 BioMérieux 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
    2013-12-23
  • 사례 출판 날짜
    2013-12-23
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131223.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: biomérieux vidas 3 system medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vidas 3 system [catalogue number: 412590]. the manufacturer was informed that some customers experienced pipetting issue on the instrument vidas 3 ref. 412590 when they use tubes with an external diameter of around 12 mm. the issue is due to a collision between a small flat step at the top of the tip and the tube edges when the pipettor is going down to aspirate in the tube. the instrument identifies the problem and errors 0956 xapu and/or 0502 (loading bay errors) happen. there is no risk to have an incorrect diagnostic because the error message will occur before having a diagnostic result. the manufacturer advises users to stop using the tubes size of 12 mm and to use tubes with a larger diameter (13 and/or 16 mm as per user manual) until corrective actions are implemented. the user manual will be updated based on the investigation results. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 december 2013.

Device

VIDAS 3 system
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: BioMérieux VIDAS 3 system
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux