Events

ARCHITECT DHEA-S Reagent Kit 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 Abbott GmbH & Co 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
  • 날짜
    2017-12-14
  • 사례 출판 날짜
    2018-01-29
  • 사례 국가
    Serbia
  • 사례 출처
    ALIMSA
  • 사례 출처 URL
    https://www.alims.gov.rs/latin/2018/01/29/vazno-obavestenje-o-medicinskom-sredstvu-architect-dhea-s-reagent-kit-imunohemija/
  • 비고 / 경고
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has identified that, when using the architect dhea-s reagent kit, samples from babies up to 60 days of age may have false results. the manufacturer is currently investigating the specific cause of the elevated results. although false elevations have been observed in infants up to 60 days of age, the reference range for children up to 10 years of age given in the test instruction manual should also not be used as the reference ranges are being tested.

Device

ARCHITECT DHEA-S Reagent Kit
  • 모델명 / 제조번호(시리얼번호)
    (8K27-20) 01316K000; 01217A000; 02217D000; 04117H000;(8K27-25)01216K000; 01117A000; 02217C000; 02317D000; 02417D000; 00517F000; 02817H000
  • Manufacturer
    Abbott GmbH & Co

Manufacturer

Abbott GmbH & Co
  • 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
    ALIMSA