Events

VITROS Chemistry Systems. An in vitro diagnostic medical device (IVD). 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-00326-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00326-1
  • 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 diagnostics (ocd) has identified instances where the vitros system allowed urine samples for assays that required acidified pre-treatment to be metered from the same sample container as assays that required no pre-treatment when the sample was programmed. the anomaly occurs when manually programming urine samples or using a downloaded sample program from a laboratory information system (lis) and the sample program contain assays requiring sample pre-treatment and assays requiring no sample pre-treatment.If this anomaly occurs, it is possible for vitros systems to process urine samples without the proper pre-treatment, potentially leading to biased patient results.
  • 조치
    The mitigation to this anomaly is currently under development. OCD will issue a follow up notification upon availability of the software update. OCD is providing users with temporary work around instructions and advising users that for urine samples that require pre-treatment to place each of the pre-treated samples in a separate container and manually program the individual samples. Also, OCD is asking users to discuss concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 04/08/2016.

Device

VITROS Chemistry Systems. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Systems. An in vitro diagnostic medical device (IVD).VITROS 4600 Chemistry System & VITROS 5600 Integrated System Software Version 3.2 & BelowProduct Codes: 6802445 & 6802413VITROS 5,1 FS Chemistry SystemSoftware Version 2.8 & BelowProduct Codes: 6801375 & 6801890Assay Data Disk (ADD)All DRV versions that support product within expiry datingProduct Code: 6801876ARTG number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics