Events

Ortho-Clinical Diagnostics Vitros 350 Chemistry Systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Ortho-Clinical Diagnostics Inc 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
    19634
  • 사례 시작날짜
    2016-11-28
  • 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: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • 원인
    Manufacturer has initiated a recall due to the need to clarify operator actions folloing u90-382 or 6lu cnditions codes generated by the system., if a u90-382 or 6lu condition code (i.E associated with a wash error) occurs, the condition code text located on the vitro system and other user documentation indicates to dilute the sample. however dilution may not be the appropriate action for all scenarios., this notification provides additional information to a product correction notification that ortho clinical diagnostics (ortho) issued in december 2015 (medsafe ref. 19634) regarding the clarification of operator actions for wash errors. since that time, ortho has been monitoring the occurrence of u90-382 or 6lu condition codes associated with wash errors. we observed an increase in wash errors for vitros chemistry products phyt slides.
  • 조치
    Manufacturer to issue advice regarding use

Device

Ortho-Clinical Diagnostics Vitros 350 Chemistry Systems

Manufacturer

Ortho-Clinical Diagnostics Inc