Events

VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics Australia Pty Ltd 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-2017-RN-00004-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-01-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00004-1
  • 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
    An issue has been identified where there is a potential for biased results to be generated over the 10 day on-analyzer limit when using vitros na+ slide cartridges warmed between 1½ to 8 hours prior to being placed on the analyser. it has been determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyser storage limit. this issue affects all expired, in-date gens, and future product until further notice.
  • 조치
    Ortho Clinical Diagnostics is advising customers to store cartridges at room temperature for a minimum of eight (8) hours prior to calibration. Customers who have discarded cartridges will have their account credited or be sent a replacement.

Device

VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd