Events

Roche Cobas Sysmex SP-10/ SP-1000 and associated transport systems (AlphaN, HST and XN-9000/3000) 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Roche Diagnostics GmbH 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
    19796
  • 사례 시작날짜
    2016-02-27
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 원인
    There have been reports overseas that sample tubes may not be correctly placed back in the rack tube transport (rtt) after the de-capping process. this may result in open tubes being dropped within the cobas p 512 pre-analytical system, contaminating the system and potentially other samples. a false triggering or detection of the “ready” signal from the lifting gripper in the decapper causes the system to register that the motor motion is finished. the system then continues with the next process step and opens the gripper prematurely., this issue may lead to contamination of the instrument and other samples. the risk to operator of contamination is less than remote. however, the contamination of other samples may lead to erroneous sample results with possible inappropriate diagnosis/treatment.
  • 조치
    Software to be upgraded

Device

Roche Cobas Sysmex SP-10/ SP-1000 and associated transport systems (AlphaN, HST and XN-9000/3000)
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Part Nos: BR362571 and 04303413
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH