SLIDEX Strepto Plus 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
    2015-10-28
  • 사례 출판 날짜
    2015-10-28
  • 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 slidex strepto plus medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its slidex strepto plus [product number: 58811; lot number: 1501111348; expiration date: 08-jan-2016]. according to the manufacturer, a customer complaint investigation confirmed a stability issue associated with slidex strepto plus latex b reagent (lot# 1501111348) when exposed to thermal shock conditions either during transportation or storage. product exposed to thermal shock exhibited weak or no agglutination. as a result of weak or no agglutination to the latex b reagent, there is a potential for a false negative result with group b streptococcus colonies. product that was stored under normal conditions was determined to perform within specifications and produce proper agglutination. in order to determine whether the product is affected by this issue, affected users are instructed to perform the following steps: prior to each use with clinical samples, perform the quality control procedure referenced within the package insert using the positive controls. if the product produces a positive result with the positive controls, as described in the “readings and interpretation of results” section of the package insert, then utilize the product to process the clinical sample(s). if the product produces a negative result with the positive controls, as described in the “readings and interpretation of results” section of the package insert, then discontinue use of that kit of the product, dispose of the affected product. 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 28 october 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: BioMerieux SLIDEX Strepto Plus
  • Manufacturer

Manufacturer