Events

Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-2014-RN-00036-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-01-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00036-1
  • 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 diagnostics has confirmed under recovery up to 50% in patient values across the assays reportable range with the affected immulite 2000/immulite 2000 xpi osteocalcin (l2kon2) kit lots. quality control materials will not detect the bias.Osteocalcin can serve as a measure of increased bone resorption in some patient. depending upon the treatment approach, the measurement of osteocalcin may correlate to therapy. in some patients risk of osteoporosis correlates of increasing values of osteoclacin.
  • 조치
    Siemens Healthcare is advising users to discontinue and discard affected lots. Siemens does not currently have a replacement for this product. Siemens is recommending discussing this notice with the medical director regarding the need to review previous test results, conduct patient follow and / or repeat testing for patients tested with the affected lots.

Device

Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. An in vitro diagnostic medi...
  • 모델명 / 제조번호(시리얼번호)
    Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD)Test Code: OCNCatalogue Number: L2KON2Lot Numbers: 218, 219, 220 & 221Siemens Material Number: 10381477ARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division