Events

IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. 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-01516-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01516-1
  • 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 has confirmed through internal investigation that certain immulite/immulite 1000/immulite 2000/immulite 2000 xpi assays are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the immulite platform. biotin interference has the potential to bias analytical results of the affected assays. the instructions for use (ifu) currently do not list biotin as a potential interferant.Concentrations of biotin above the determined concentration can potentially result in interference greater than 10%, leading to either falsely elevated or falsely depressed results. cea, folic acid, om-ma (ca125) and vitamin b12 exhibited falsely elevated results with the determined biotin concentrations.3gallergy specific ige, anti hbc, br-ma (ca15-3), ck-mb, epo, gastrin and thyroglobulin exhibited falsely depressed results with determined biotin concentrations.
  • 조치
    Siemens is providing users with updated information regarding biotin interference and updating the Instructions for Use (IFU).

Device

IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical dev...
  • 모델명 / 제조번호(시리얼번호)
    IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical device (IVD)Affected Multiple Assay Numbers, Catalogue Numbers and Material NumbersARTG: 179719, 180780, 180969, 179720, 179721
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd