Events

Beckman Coulter UniCel DxC Synchrom Systems No Foam Reagent 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Beckman Coulter Inc 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
    20362
  • 사례 시작날짜
    2016-07-06
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • 원인
    An iincompatibility between no foam dxc reagent (ref b64130) and the dxc hydropneumatic parts associated with no foam delivery has been identified., dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. over time, this incompatibility may lead to:, - breaks in no foam cap assembly, - cracks in no foam waste collector; and, - seepage outside no foam tubing, this issue may lead to cracks in the waste collector which may stop instrument operation due to vacuum error, and potentially lead to biohazardous waste exposure.
  • 조치
    Manufacturer to issue advice regarding use

Device

Beckman Coulter UniCel DxC Synchrom Systems No Foam Reagent
  • 모델명 / 제조번호(시리얼번호)
    Model: B64130, Affected: All lots
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc