Automate 2550 and 1250, Aliquotter Tip Present Sensor 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
    2018-01-31
  • 사례 출판 날짜
    2018-01-31
  • 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 automate 2550 and 1250, aliquotter tip present sensor medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its automate 2550 and 1250, aliquotter tip present sensor. the manufacturer has identified a rare potential issue with the tip present sensor within the robot of the aliquoter module. there has been one report of a misaligned sensor in an automate system, which resulted in the system processing samples without pipette tips. a small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. in this particular case, the system gave no external sign of a misaligned tip present sensor. according to the manufacturer, there is no impact to the sorter module associated with this issue. in the remote instance that a sensor is misaligned, and the system does not trigger the error message that a tip is not present, there is a remote chance of sample cross-contamination. as a precautionary measure, the manufacturer has instructed field service engineers to inspect the tip present sensor for misalignment at their next service visit. if the users suspect or observe unusual contamination of the tip carrier arm while performing daily maintenance, as described in the instructions for use, they are recommended to contact the local supplier and discontinue use of the aliquotter module. 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 31 january 2018.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Beckman Coulter Automate 2550 and 1250, Aliquotter Tip Present Sensor
  • Manufacturer

Manufacturer