Events

Automate 2550 and 1250 Aliquotter Tip Present Sensor.An in vitro diagnostic medical device 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00084-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-02-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00084-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Beckman coulter has identified a potential issue with the tip present sensor within the robot of the aliquoter module. there has been one overseas 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. there is no impact to the sorter module associated with this issue.
  • 조치
    Beckman Coulter will arrange field service engineers to inspect affected devices to inspect the tip present sensor for misalignment. If users suspect or observe unusual contamination of the tip carrier arm whilst performing daily maintenance, as described in the IFU please contact the local Beckman Coulter representative immediately. If this is to occur, it is recommended to discontinue use of the Aliquotter module.

Device

Automate 2550 and 1250 Aliquotter Tip Present Sensor.An in vitro diagnostic medical device

Manufacturer

Beckman Coulter Australia Pty Ltd