Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Abbott 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 067 12 17 000
  • 사례 시작날짜
    2017-12-19
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11901
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Abbott has identified that falsely elevated results may be obtained when using the architect dhea‐s assay with samples from infants up to 60 days old. the specific cause of the elevated results is currently under investigation.

Device

ARCHITECT DHEA‐S Reagents
  • 모델명 / 제조번호(시리얼번호)
    Product Product Name List Number Lot Number UDI ARCHITECT DHEA‐S Reagents 8K27‐20 01316K000 (01) 00380740017446 (17) 180204 (10) 01316K000 (240) 8K2720 01217A000 (01) 00380740017446 (17) 180413 (10) 01217A000 (240) 8K2720 02217D000 (01) 00380740017446 (17) 180624 (10) 02217D000 (240) 8K2720 04117H000 (01) 00380740017446 (17) 181125 (10) 04117H000 (240) 8K2720 ARCHITECT DHEA‐S Reagents 8K27‐25 01216K000 (01) 00380740017453 (17) 180204 (10) 01216K000 (240) 8K2725 01117A000 (01) 00380740017453 (17) 180413 (10) 01117A000 (240) 8K2725 02217C000 (01) 00380740017453 (17) 180617 (10) 02217C000 (240) 8K2725 02317D000 (01) 00380740017453 (17) 180624 (10) 02317D000 (240) 8K2725 02417D000 (01) 00380740017453 (17) 180624 (10) 02417D000 (240) 8K2725 00517F000 (01) 00380740017453 (17) 180902 (10) 00517F000 (240) 8K2725 02817H000 (01) 00380740017453 (17) 181021 (10) 02817H000 (240) 8K2725
  • 제품 설명
    IVD Test Reagent/Kits, Immunoassay
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • 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.
  • 제조사 대표
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA