Muller Hinton 2 agar + 5% sheep blood 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
    2016-08-18
  • 사례 출판 날짜
    2016-08-18
  • 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: biomerieux muller hinton 2 agar + 5% sheep blood medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its muller hinton 2 agar + 5% sheep blood [reference number: 43329, 43321 and 43324]. during an internal investigation, the manufacturer observed that the use of the medium mueller hinton 2 agar + 5% sheep blood (mh-s) (ref. 43329-43321-43324) with the cotrimoxazole antibiotic (= trimethoprime-sulfamethoxazole) (sxt) could lead to false susceptible results for s. pneumonia and streptococci strains with a disc diffusion method whatever is the shelf-life of the media. according to the manufacturer, results for others combinations strains-antibiotics that could be tested on mh-s medium (ref. 43321-43329-43324) are conform to the expected results. results on (mh2-f) (ref. 41864) bottle and mueller hinton 2 agar (mh2-d) (ref. 51075-51860) regarding the sxt antibiotic are conform to the expected results the manufacturer is advising users do not use the affected products with the sxt antibiotic whatever the strain that could be tested. the users can use (mh2-f) (ref. 41864) bottle and mueller hinton 2 agar (mh2-d) (ref. 51075-51860) with 5% sheep blood with the sxt antibiotic as products performed within the specifications. 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 18 august 2016.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: BioMerieux Muller Hinton 2 agar + 5% sheep blood
  • Manufacturer

Manufacturer