Dimension Vista Systems LOCI Thyroid Stimulating Hormone. 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-2015-RN-00357-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-23
  • 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 determined that dimension vista loci thyroid stimulating hormone (tsh) lot 14237aa may produce results with a negative bias ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a flex well. the occurrence of this issue is low. quality control will detect the issue if it is run near the end of an affected well set. the potential for clinical impact as a result of this issue is limited to a delay in hypothyroidism investigations. when this issue occurs, it is likely the negatively biased tsh values will not correlate reciprocally with free or total thyroid hormone values. in cases of monitoring tsh suppression for thyroid cancer, the potential for clinical misinterpretation of a patient’s response to thyroid hormone replacement therapy exists.
  • 조치
    Siemens is instructing customers to discontinue and discard remaining inventory of the affected lot as a result of this issue. A look back at the previously generated results using the affected lot is recommended provided the sample is within the specified storage conditions and time, and where a TSH value within or below the reference interval did not reciprocally correlate with free or total thyroid hormone values.

Device

  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista Systems LOCI Thyroid Stimulating Hormone. An in vitro diagnostic medical device (IVD)Assay: TSHCatalogue Number: K6412Siemens Material Number (SMN): 10445104Lot Number: 14237AAARTG number : 180109
  • Manufacturer

Manufacturer