Events

A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 Lasers (Navios Flow Cytometers). In vitro diagnostic medical devices (IVD) 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-2013-RN-00056-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-01-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00056-1
  • 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 an internal wiring problem in certain navios reagent carts that may result in a severe shock hazard and instrument failure or shut down. during manufacture the compressor cable assembly may have been installed in a configuration that would allow the wiring to come into contact with the compressor frame during operation. normal vibration of the compressor frame could wear through the wiring's shielding and insulation material and connect electrical current to the reagent cart housing, resulting in the potential exposure of a user or service engineer to a severe shock hazard.
  • 조치
    If the compressor fails or the system shuts down unexpectedly, unplug the laboratory power source and call Beckman Coulter Customer Service. A Beckman Coulter service engineer will be contacting the affected customers to arrange for an inspection of the device and make all necessary corrections if an issue exists with the wiring within the compressor module.

Device

A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 La...
  • 모델명 / 제조번호(시리얼번호)
    A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 Lasers (Navios Flow Cytometers). In vitro diagnostic medical devices (IVD)Part number A52101 serial numbers earlier than AU50137 are affectedPart number A52102 serial numbers earlier than AU50014 are affectedPart number A52103 serial numbers earlier than AU45311 are affected
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd