Events

VIDAS CA 15-3 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 bioMerieux 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
    2018-07-18
  • 사례 출판 날짜
    2018-07-18
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180718a.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: biomerieux vidas ca 15-3 medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its vidas ca 15-3 [reference: 30429; lot number: 1006022590 and 1006251930]. following customers’ complaints for calibrations out of range (standard s1 out of range low and/or control c1 out of range high) when using the affected lots, investigators confirmed a defect on the identified products and reproduced the issue reported by the customers. the manufacturer has identified that s1 signal decrease was probably due to a particular lot of raw material (bovine albumin) which is a component of standard s1, which was not performing as expected. the lot of raw material was not used for the manufacturing of any other product. it has been established that standard s1 will continue to decrease over time, what will lead both lots of finished products to be unusable due to invalid calibrations. investigators showed that control c1 is conforming expected specifications. its relative fluorescence value (rfv) does not evolve overtime. the c1 out of range high reported by some customers is not linked to a signal increase but is due to standard s1 decrease. according to the manufacturer, as the vidas systems trigger an alarm in case of invalid calibration, the defect is easily identified. the identified issue can lead to delayed results. there is no risk for false results. the defect (standard s1 signal decrease) can have two impacts on the finished product: standard s1 is obtained out of range low at the opening of the kit: the kit cannot be calibrated and cannot be used, what leads to delayed results. control c1 is obtained out of range high at the time of the recalibration: the kit cannot be calibrated and cannot be used, what leads to delayed results. affected users are instructed to destroy the impacted lots. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 18 july 2018.

Device

VIDAS CA 15-3
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: bioMerieux VIDAS CA 15-3
  • Manufacturer
    bioMerieux

Manufacturer

bioMerieux