Events

Amylase Assay used with ADVIA Chemistry Systems 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-00340-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00340-1
  • 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 that the affected amylase reagent kit demonstrate an increased incidence of absorbance flags (u or u accompanied by u). absorbance flags (u) indicate an abnormally high reagent blank absorbance exceeding the reagent blank limit. in some cases with these reagent lots, sample results may also have a sample absorbance (u) flag indicating a high absorbance for the sample that occurs in conjunction with the (u) flag. amylase results can be generated with these flags. the risk to health is limited to a potential delay in amylase testing.
  • 조치
    Siemens is advising users that if a sample (u) flag occurs where there are no absorbance (U) flags, the flag is sample related and the sample should be re-tested. Siemens is advising users who choose not to continue using the affected batches, that Siemens will replace the affected lots. The look back of previously generated results is at the discretion of the laboratory. This action has been closed-out on 07/09/2016.

Device

Amylase Assay used with ADVIA Chemistry Systems
  • 모델명 / 제조번호(시리얼번호)
    Amylase Assay used with ADVIA Chemistry SystemsTest Code: AMYLASCatalogue Numbers: 07498401 & 03031177Siemens Material Numbers: 10309493 & 10341130Lot Numbers: 304821 & 304816Expiration Date: April 2015 ARTG number: 176331An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division