Events

cobas e 801 syringe plunger issue 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
    22805
  • 사례 시작날짜
    2018-04-13
  • 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
    The manufacturer has received complaints describing an issue with the syringe plunger on the cobas e 801 module prewash syringe assembly. investigations determined that the issue may also occur on the cobas e 801 module r1 or r2 reagent assembly. depending on the affected syringe, r1, r2 or prewash, liquids may not be pipetted correctly due to the syringe plunger being damaged. depending on how the seal pieces are assembled, it is possible that the plunger is mounted in a tilted position, which applies mechanical stress to the plunger. during the cobas e 801 module initialization steps when the largest stokes happen, the plunger may crack leading to an impaired syringe function.
  • 조치
    Product to be modified

Device

cobas e 801 syringe plunger issue

Manufacturer

Roche Diagnostics GmbH