Events

Clearview HCG Pregnancy Test Kit 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Unipath Limited 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
    Field Safety Notice
  • 사례 연번
    SN2007(02)
  • 날짜
    2007-06-12
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/clearview-hcg-pregnancy-test-kit&id=e099f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • 데이터 추가 비고
  • 원인
    Lot hg0050 of the clearview hcg pregnancy test kit (cat number 500158) has been recalled by the manufacturer due to the potential for false negative results i.E. a negative result obtained in pregnancy.
  • 조치
    Action or Recommendations for Healthcare Professionals Ensure that all relevant staff in your institution are informed of this recall   Determine if you have lot number HG0050 of the above product Locate and cease using product from lot number HG0050   Determine how much of this product has been used   Follow the distributor / manufacturer recommendations for quarantine and disposal of product Follow up patients as required Action or Recommendations for Patients Patients who have had a recent pregnancy test in hospital but are concerned that the negative result received may be incorrect should contact or seek a retest from their GP, family planning clinic or pharmacist.

Device

Clearview HCG Pregnancy Test Kit
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Clearview HCG Pregnancy Test Kit
  • Manufacturer
    Unipath Limited

Manufacturer

Unipath Limited
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HPRA