Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-00196-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-08
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 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 specific reagent lots 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. 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 affected 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. this issue does not impact the immulite/immulite1000 platforms.
  • 조치
    Siemens is advising that reconstituted adjustor lots 124 and 125 are to be stored at 2-8°C or -20°C for up to 14 days, after which they must be discarded. Based on the recommended calibration interval, this allows two calibration events at day 1 and 14 after opening the SHBG reagent kit. Replacement product can be requested from Siemens if adjustors available in the laboratory are not sufficient to utilise the full reagent kit. The customer letter should be reviewed by the laboratory Medical Director and review of previously generated results is at the discretion of the laboratory.

Device

  • 모델명 / 제조번호(시리얼번호)
    Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). An in vitro diagnostic medical device (IVD).Catalogue Number: L2KSH2Siemens Material Number: 10381198Lot Numbers: 357 (Exp. 30 Jan 2017), 358 (Exp. 31 Mar 2017), 360 (Exp. 30 Apr 2017), 361 (Exp. 31 May 2017), 363 (Exp. 30 Jun 2017)ARTG number: 179720
  • Manufacturer

Manufacturer