Events

VITROS 5,1 FS System 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-2015-RN-00607-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00607-1
  • 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
    Ortho clinical has received two complaints:1) when a customer installed the add that supported the new vitros chemistry products hba1c reagent kit, the vitros 5,1 fs system posted the two condition codes ua7-239 and syd-024. the condition codes occurred because the short assay name for the new vitros assay had the same name as a user defined assay currently in use on their vitros 5,1 fs system. as a result, the user defined assay target was deleted from their system.2) when a customer installed the add, their system became unresponsive (screen freeze occurred) that required the vitros 5,1 fs system to be restarted; the system posted condition code uz0-047 after the restart was initiated.Due to a software coding error, for both scenarios, all default settings were restored from the add instead of retaining the user modified (configured) parameters and the operator was not alerted by the system.
  • 조치
    OCD has determined that the root cause of this anomaly is due to an error in the software code. The resolution is currently under development and will be available in a future version of software. In the interim, OCD has provided workaround instructions to assist end users mitigate this issue. This action has been closed-out on 15/08/2016.

Device

VITROS 5,1 FS System
  • 모델명 / 제조번호(시리얼번호)
    VITROS 5,1 FS SystemProduct Codes: 6801375 and 6801890Unique Device Identifier Number: 10758750001132 and 10758750001644ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics