Events

ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Abbott Laboratories 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
    SN2014(05)
  • 날짜
    2014-02-21
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/architect-intact-pth-assay-reagents-calibrators-and-controls&id=7978f825-9782-6eee-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
    Abbott has confirmed that a performance shift in the architect intact parathyroid (pth) assay has the potential to generate falsely elevated results on patient samples.  this issue affects architect intact pth assay list number 8k25, reagents (8k25-20, 8k25-25, 8k25-27*), calibrators (8k25-01) and controls (8k25-10). refer to attached field safety notice (fsn).  the scope of the issue affects devices manufactured between may 2012 and november 2013.  *note: this list number is not ce-marked and is distributed to usa and puerto rico only.
  • 조치
    Abbott has launched a product recall for affected lots of ARCHITECT Intact PTH assay reagents, calibrators and controls and has issued a FSN to provide instructions on what actions your laboratory must take (as follows):  - Immediately discontinue use of, and destroy, any remaining inventory of ARCHITECT Intact PTH assay according to your laboratory procedures.  - To continue Intact PTH testing at your laboratory, Abbott recommends that you identify an alternate method for testing patient samples. If further guidance is needed, please contact your Abbott sales representative.  - This letter should be reviewed with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary.  - If you have forwarded any product to other laboratories, please inform them of this FSN.  The IMB recommends that results with the ARCHITECT Intact PTH assay are reviewed as appropriate to determine whether re-evaluation of the patient is necessary.  Please forward this safety notice to all those who need to be aware of this action within your organisation and to maintain awareness over this safety notice for an appropriate time period.

Device

ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    ARCHITECT Intact PTH Assay Reagents, Calibrators and Controls
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 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