UNICEL DXC 600I SYNCHRON ACCESS CLINICAL ANALYZER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 BECKMAN COULTER CANADA L.P. 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
    97031
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-07-11
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Beckman coulter has confirmed that the dxc 600i system can generate a "cta cable down - lost connection" error (error code: 0x139f0074) that requires rebooting the cta. the "cta cable down - lost connection" error will not occur on dxc systems that do not use closed tube sampling (cts) tracking. this event will only occur on dxc systems that have cts tracking enabled. this issue can affect dxc 600i systems that have cts tracking enabled when any of the following occur: - sample id's are cleared on any networked dxc system - a networked dxc 600i is rebooted - any dxc system networked to a dxc 600i is rebooted.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 4767 (Lot serial: > 10 numbers contact mfg); Model Catalog: A25638 (Lot serial: > 10 numbers contact mfg)
  • 제품 설명
    UNICEL DXC 600I SYSTEM CLOSED TUBE ALIQUOTTER (CTA) UNIT
  • Manufacturer

Manufacturer