10% Neutral Buffered Formalin 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Thermo Scientific Richard-Allan Scientific 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
    2014-10-17
  • 사례 출판 날짜
    2014-10-17
  • 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: thermo scientific richard-allan scientific 10% neutral buffered formalin the u.S. food and drug administration (fda) posted a medical device safety alert concerning 10% neutral buffered formalin (nbf), manufactured by thermo scientific richard-allan scientific. the product details are as follows: cardinal health prefilled buffered 10% formalin (product code: c4320-450b; lot no.: 300403); richard-allan scientific specimen transportation system (product code: 53151 and 534801; lot no.: 300143 and 296986); richard-allan scientific 10% nbf (product code: 51401 and lc-0060; lot no.: 300649 and 300445); richard-allan scientific bio-tite specimen containers (product code: 59601; lot no.: 300233); protocol 10% nbf product (product code: 426-796; lot no.: 298987) the affected lots could have nbf concentrations that are lower or higher than the desired specifications. for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=69276&w=10152014??eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 17 october 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Thermo Scientific Richard-Allan Scientific 10% Neutral Buffered Formalin
  • Manufacturer

Manufacturer