Events

IMMULITE® 2000 IMMULITE® 2000 XPi 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Siemens Healthcare Diagnostics Inc. 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 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare diagnostics has confirmed that the immulite 2000®/immulite 2000 xpi® sex hormone binding globulin (shbg) adjustor lots 124 and 125 packed with reagent lots listed in table 1 do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8°c, as published in the instructions for use (ifu). reconstituted adjustors stored at 2-8°c after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. the reagent lots listed below can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg concentrations of 5 nmol/l to 170 nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not concentration dependent. .

Device

IMMULITE® 2000 IMMULITE® 2000 XPi
  • 모델명 / 제조번호(시리얼번호)
    IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 357 2017/01/30 2016/03/08 2016/03/11 IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 358 2017/03/31 2016/05/04 2016/05/06 IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 360 2017/04/30 2016/06/13 2016/06/15
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Inc.