Events

ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). 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-00247-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00247-1
  • 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 is providing an update to all advia chemistry systems lactate dehydrogenase l-p (ldlp) and lactate dehydrogenase p-l (ldpl) assay instructions for use (ifu). the current intended use section within in the advia chemistry systems lactate dehydrogenase ifu document contains the following statements which will be removed (given these assays are not validated to monitor for cancer therapy):"advia chemistry ldlp: they may also be used to monitor cancer therapy.Advia chemistry ldpl: they may also be used to monitor extensive cancer and cancer therapy.".
  • 조치
    Siemens is advising users to refer to the revised intended use statement in the notification in order to use the assays as defined. Users will be provided with the updated IFU when it becomes available.

Device

ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).ADVIA Chemistry Lactate Dehydrogenase L-PTest Code: LDLPReference Numbers: 07502115 (40 mL) & 03029628 (70 mL)Siemens Material Numbers: 10309501 (40mL) & 10341128 (70 mL)ADVIA Chemistry Lactate Dehydrogenase P-LTest Code: LDPLReference Numbers: 07502999 (40 mL) & 03030863 (70 mL)Siemens Material Numbers: 10309502 (40 mL) & 10341129 (70 mL)All LotsARTG Number: 176331
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd