IRISpec CA/CB/CC control 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Iris Diagnostics. 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
    2017-08-30
  • 사례 출판 날짜
    2017-08-30
  • 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: beckman coulter irispec ca/cb/cc control beckman coulter has issued a medical device safety alert concerning the irispec ca/cb/cc control, manufactured by iris diagnostics. [reference numbers: 800-7702 and 800-7702-fjr]. the manufacturer has become aware of an issue in which results for the irispec cb control for urobilinogen may fall below the lower limit of the stated quality control range. the irispec cb control may intermittently fail for the urobilinogen analyte when run on the ichemvelocity. the customer’s laboratory will be unable to process patient samples until quality control passes. this will not affect patient sample results. a new lower limit on the urobilinogen control range is being implemented to align the published ifu range with that of the allowable product claims per beckman coulter’s design requirements. the irispec ca/cb/cc package insert (and strip package insert information related to controls) will be updated to reflect changes to the lower limit of the qc range. customers are recommended to take the following actions: implement the use of the following revised quality control ranges for irispec cb urobilinogen for the ichemvelocity refer to the ichemvelocity operato’s manual (p/n 300-4449fe, appendix a; entering consumables data) to change the qc range or contact the manufacturer for assistance. disregard any information related to control specifications that are outlined in strip package insert. 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 30 august 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Beckman Coulter IRISpec CA/CB/CC control
  • Manufacturer

Manufacturer