Events

BD BBL Crystal Enteric/Nonfermenter ID Kit 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 BD Diagnostic Systems 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
    2012-12-28
  • 사례 출판 날짜
    2012-12-28
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121228.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: bd bbl crystal enteric/nonfermenter id kit medical device manufacturer, bd diagnostic systems, has issued a medical device safety alert concerning bbl crystal enteric/nonfermenter id kit. the affected catalogue number is 245000 and the affected lot numbers are 2086315, 2101435, 2104316, 2129460, 2129487, 2163211, 2163213, and 2163215. bd has determined through complaint investigation that the above referenced products have the citrate (cit) and malonic acid (mlo) reagents in the reversed prong/well positions. this may lead to no-identification or multiple identification choices. customers specifically reported split identification results between citrobacter and salmonella; however, other bacterial identifications requiring the use of these two substrates may also be affected. according to the local supplier, the affected products have been distributed in hong kong. bd advised the affected customers to discontinue use of the affected lots and discard any remaining packages. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 december 2012.

Device

BD BBL Crystal Enteric/Nonfermenter ID Kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: BD BBL Crystal Enteric/Nonfermenter ID Kit
  • Manufacturer
    BD Diagnostic Systems

Manufacturer

BD Diagnostic Systems