Events

VITROS Chemistry Products C-reactive protein (CRP) Slides 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-2016-RN-01427-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01427-1
  • 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 (ortho) received reports of positively biased crp results using vitros crp slides when diluting samples. investigation undertaken by ortho identified that samples diluted (3x recommended dilution or higher) using vitros chemistry products specialty diluent, vitros chemistry products fs diluent pack 3 or a low crp concentration sample had positively biased results if the endogenous level of crp in the diluent is not subtracted from the final result. the magnitude of bias increases as the dilution factor increases.
  • 조치
    Users are advised to follow the instructions in the customer letter to perform dilutions when processing samples above the measuring range for CRP. VITROS CRP Slides Instructions for Use (IFUs) will be revised to include the additional instructions to follow when diluting samples with results above the measuring range. Discuss any concerns regarding previously reported CRP results with the Laboratory Medical Director to determine the appropriate course of action. The results from this or any other diagnostic test should be used and interpreted only within the context of the overall clinical picture. This action has been closed-out on 26/05/2017.

Device

VITROS Chemistry Products C-reactive protein (CRP) Slides
  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products C-reactive protein (CRP) SlidesProduct Codes: 1926740, 8097990Unique Identification Numbers: 10758750000296, 10758750004355Affected Generations (GENs): 3, 11, 12, 30 through 36This issue may affect expired, current (in date) and future product GENsARTG Number: 232251
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd