Events

OrthoBioVue multi-reagent cassettes 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Ortho Clinical Diagnostics 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/058
  • 사례 연번
    CON297526
  • 날짜
    2013-07-26
  • 사례 출판 날짜
    2013-07-26
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297526?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    A small number of multi-reagent cassettes in affected lots have been found with labels containing product information on the wrong side of the cassette. the use of affected multi-reagent cassettes may lead to false negative or false positive results, causing a potential misclassification of the patient or donor blood groups or rh/k phenotypes or incorrect antibody detection results.  this may be of particular clinical concern where there is no confirmation of the group (e.G. in testing of newborns or where reverse grouping is not in place). ortho clinical diagnostics have sent out a field safety notice having identified the cause of the manufacturing issue.
  • 조치
    Do not use and quarantine products from affected lots received prior to 5 July 2013.  Contact the manufacturer urgently for replacement product. Products from affected lots received prior to 5 July 2013 should be used only where no alternative stock is available and must be inspected prior to use (see manufacturer’s Field Safety Notice). Discard products from affected lots received prior to 5 July 2013 once replacement stock is available for use. Consider the need to review patient results from the affected lots. As part of your look back process, report any incorrect results to the MHRA and Ortho Clinical Diagnostics. Directors of pathology Lead clinical scientists (haematology) Lead biomedical scientists (haematology and blood transfusion) Clinical services managers Laboratory managers

Device

OrthoBioVue multi-reagent cassettes
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Blood grouping cassettes. OrthoBioVue multi-reagent cassettes. See the manufacturer’s Field Safety Notice for a list of affected products and lot numbers. Products received by you after 5 July 2013 were inspected by the manufacturer prior to shipping. NOTE: There is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent.
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics