Events

Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 N/A 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/2013/012
  • 사례 연번
    CON249673
  • 사례 출판 날짜
    2013-03-19
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON249673?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
    Health canada (the canadian regulatory authority for medical devices) has suspended sale of these kits in canada due to concerns about the manufacturer’s quality systems – see: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/23151a-eng.Php health canada's decision to suspend these licences is not based on an identified issue with the safety and effectiveness of any particular device. the mhra has not received any reports of adverse incidents in the uk involving these devices. the product is currently still available for use in the uk the mhra is continuing to monitor this situation.
  • 조치
    Users should report any incidents of false results involving these products to the MHRA and the supplier, to enable the MHRA to monitor the situation in the UK. Note: the MHRA will consider the need to issue further advice based upon information received from UK users. Healthcare personnel treating patients based on results from test strips. Healthcare personnel using, supplying, supervising, quality assuring or distributing these test strips.

Device

Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opi...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    "Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing, manufactured by: IND Diagnostics Inc, Canada Alere International Ltd Barrier Healthcare Ltd E-Pharm Ltd The table below lists test strips that have been supplied in the UK between January 2011 and March 2013 Manufacturer Device Type Device Name IND Diagnostics Urinalysis Reagent Test Strips Urinalysis Reagent Test Strips IND Diagnostics HCG Pregnancy Test Indicator One-Step Urine Pregnancy Test (Cassette Format) Indicator One-Step Urine Pregnancy Test (Ministrip Format) Indicator One-Step Home Pregnancy Test (Midstream Format) Indicator One-Step Home Pregnancy Test (Mini-Midstream Format) IND Diagnostics FSH Menopause tests One Step FSH Menopause Test (Strip Format) One Step FSH Menopause Test (Cassette Format) One Step FSH Menopause Test  (Midstream Format) IND Diagnostics Opiates Test IND One Step Opiates Test Alere International Ltd. HCG Pregnancy test Axis Shield Pregnancy test dipstick and cassette Barrier Healthcare Ltd Urinalysis Reagent Test Strips DIA-CHECK Urinalysis Reagent Strips E-Pharm HCG Pregnancy Test PREGTEST (Strip format) PREGTEST (Cassette format) PREGTEST (Midstream format)"
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    MHRA