Events

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System 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-2016-RN-01049-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-08-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01049-1
  • 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 received and confirmed a report of a fire within the stainer module of a customer’s dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module’s methanol bath. users are being advised to discontinue use of the stainer module to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire. beckman coulter is actively investigating the reported incident to determine the root cause, and define and implement required corrective and preventive actions.
  • 조치
    Beckman Coulter is advising users to: 1. Immediately discontinue use of the Stainer module. 2. Drain all liquids from the Stainer module. 3. Follow the directions provided for placing the Stainer module in extended shutdown and disabling the Stainer. Once the Stainer has been disabled, the Slidemaker module may be used to prepare slides for staining. Slides must be stained using an alternative method. A Beckman Coulter service representative will schedule a visit to modify the Stainer module so that it remains disabled and cannot be used until further corrective action is implemented. This action has been closed-out on 02/03/2017.

Device

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

Manufacturer

Beckman Coulter Australia Pty Ltd