Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and 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-2013-RN-00915-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-30
  • 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
    The immulite/ immulite 1000/ immulite 2000 and immulite 2000 xpi free t3 assay kit lots listed with adjustor (lf3l/h) lot #135 are showing an elevated shift in patient values that exceed the upper limits of the normal reference range referenced in the immulite free t3 instructions for use (ifu). the elevated immulite free t3 results will not correlate with the results of other thyroid markers or free t3 results generated on other platforms.
  • 조치
    Siemens is requesting their customers to cease using the affected lots of reagent. Replacement with unaffected lots can be arranged to replace any stock. A look back of previously reported results is not recommended by Siemens as the assessment of thyroid function is generally based on multiple markers. However, the requirement for a look back should be determined at the discretion of the laboratory. Thia action has been closed-out on 29/01/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD).IMMULITE/IMMULITE 1000 FT3Catalog Number: LKF31Siemens Material Number: 10381626Lot Numbers: 353 & 354IMMULITE 2000/IMMULITE 2000 XPi FT3Catalog Numbers: L2KF32 & L2KF36Siemens Material Numbers: 10381675 & 10381682Lot Numbers: 737, 738, 739, 740, 741, 742 & 743ARTG number: 179720
  • Manufacturer

Manufacturer