Events

VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems (Software Versions 3.0 & below) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 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-2014-RN-00765-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00765-1
  • 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
    Internal investigation confirmed that under specific circumstances, patient demographics may be incorrectly associated with a sample id number. this issue may occur when condition code py1-075 is generated for a sample id and the operator does not follow the instructions provided below in the condition review in v-docs.
  • 조치
    End users are advised to move the sample to different cup and position if a PY1-075 condition code occurs on your VITROS® 3600, 4600 or 5600 System during sample processing. A correction will be included in the next scheduled software update. This action has been closed-out on 06/07/2016.

Device

VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Syst...
  • 모델명 / 제조번호(시리얼번호)
    VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems (Software Versions 3.0 & below) VITROS 3600 Immunodiagnostic System System Product Code: 6802783 VITROS 4600 Chemistry System System Product Code: 6802445 VITROS 5600 Integrated System System Product Code: 6802413
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics