Events

Clinitest® hCG Cassette Pregnancy Test Kit 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Siemens Healthcare 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
    Field Safety Notice
  • 사례 연번
    SN2011(33)
  • 날짜
    2011-12-19
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/clinitest-hcg&id=5580f825-9782-6eee-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
    Lots 028619, 028924, 029997, 030240, 030431, 030602, 030826, 030998, 031332, 031460, 031662, 031798, 031924, 032106 and 032180 of the clinitest hcg pregnancy test kits have been recalled by the manufacturer due to the potential for borderline or false positive results with commercially available controls and patient samples.
  • 조치
    ACTION OR RECOMMENDATIONS FOR HEALTHCARE PROFESSIONALS  • Ensure that all relevant staff in your institution are informed of this  recall  • Determine if you have lots 028619, 028924, 029997, 030240, 030431,  030602, 030826, 030998, 031332, 031460, 031662, 031798, 031924,  032106, and 032180 of the above product  • Locate and cease using product from the lots listed above  • Determine how much of this product has been used  • Follow the distributor / manufacturers recommendations for quarantine  and disposal of product  • Follow up with patients as required.  ACTION OR RECOMMENDATIONS FOR PATIENTS  • Patients who have had a recent pregnancy test administered by a healthcare  professional but are concerned that the positive result received may be  incorrect should contact or seek a retest from their GP, family planning  clinic or pharmacist.

Device

Clinitest® hCG Cassette Pregnancy Test Kit

Manufacturer

Siemens Healthcare Diagnostics