Events

Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption, Alegria Anti-Intrinsic Factor Assay (ORG-247-24) 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Orgentec Diagnostika GmbH 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/2013/041
  • 사례 연번
    CON286935
  • 날짜
    2013-06-19
  • 사례 출판 날짜
    2013-06-19
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286935?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
    Deterioration in the activity of affected lots may lead to false negative results outside of the manufacturer’s claims for performance (61.2% sensitivity). a false negative could result in a delay in diagnosis or treatment of vitamin b12 malabsorption. laboratory internal quality control systems may not detect this deterioration. orgentec issued a product notification letter in which they mention a further lot - 24723945 (expiry 28/02/2014). this lot has also shown a deterioration in activity in a recent uk neqas haematinics distribution.
  • 조치
    Do not use devices from the affected lot. Consider the need to review previous negative results from tests performed using the affected lot. Where results are inconsistent with the clinical picture, samples should be retested with a different lot number. It may be necessary to arrange for repeat samples. Contact Launch Diagnostics (01474 876 402) to request replacement strips for retesting. Clinical pathologists Biomedical scientists

Device

Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption, Alegria Anti...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Laboratory test kit: Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption. Alegria Anti-Intrinsic Factor Assay (ORG-247-24) lot number 24723031 expiry 30/11/2013.
  • Manufacturer
    Orgentec Diagnostika GmbH

Manufacturer

Orgentec Diagnostika GmbH