Events

UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Beckman Coulter 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
    2016-05-09
  • 사례 출판 날짜
    2016-05-09
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160509.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: beckman coulter unicel dxh 800 and unicel dxh 600 coulter cellular analysis systems medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxh 800 and unicel dxh 600 coulter cellular analysis systems. the affected products are identified as follows: unicel dxh 800 coulter cellular analysis system reference.: 629029, b24465, b24802, b68304 software version: 2.0.0.0 and greater unicel dxh 600 coulter cellular analysis system reference: b23858 software version: 1.0.0.0 and greater the manufacturer has identified an issue where the rbc aperture baths can contain residue in the sweep flow fittings. this residue may potentially create increased background failures, flagged results and vote outs for rbc and plt parameters. affected users are instructed to: address any daily checks system alarms and background failures as indicated in the online help or instructions for use (part number b26647ac and b16421ad); and monitor flags on patient and control results according to their laboratory protocols. according to the local supplier, unicel dxh 800 coulter cellular analysis system is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 may 2016.

Device

UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Beckman Coulter UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter