UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611). An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter Australia 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-2016-RN-01619-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-13
  • 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
    Beckman coulter has determined that certain lots of dxc wash concentrate ii can cause a failure in calibration of thermo-fisher lithium reagent (ref a19611). the consequence of calibration failure does not allow for patient results to be generated. lithium calibration failure can potentially lead to a delay of reporting lithium results. patient results reported under acceptable calibration and quality control evaluation are not affected by this issue.
  • 조치
    Beckman Coulter is advising Thermo-Fisher Lithium assay users to discontinue use of affected DxC Wash Concentrate II lots and discard any unused reagent bottles. Replacement product will be provided. Reassessment of past results is not required.

Device

  • 모델명 / 제조번호(시리얼번호)
    UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611). An in vitro diagnostic medical device (IVD).Wash Concentrate IIReference Number: 445865Lot Numbers: Z505212 (expiry 30 April 2017), Z507201 (expiry 30 June 2016), Z511202 (expiry 31 October 2017)ARTG Number: 245295
  • Manufacturer

Manufacturer