Events

ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. 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-2018-RN-00310-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00310-1
  • 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 platelet clump flags (plt-clm) are generated in the perox channel of the advia 120/2120/2120i haematology system while running cbc/diff (complete blood count / differential) whole blood samples with diff timepac perox 1 reagent lot # 57211, in samples without platelet clumps. the accuracy of the platelet results are not impacted when the perox 1 reagent (lot 57211) is used on the system and a plt-clm flag is generated due to this issue. additionally, platelet results are reported from the red blood cell/platelet (rbc/plt) channel and not measured in the perox channel where platelet clumps are detected. however, the platelet results will be flagged if the clump count is greater than 300, directing the user to investigate the sample.
  • 조치
    Siemens is requesting customers discontinue use of and discard the entire lot of ADVIA 120/2120/2120i DIFF TIMEPAC products listed in Table 1 of the Customer Letter. Complete and return the Response Form attached to the Customer Letter by Friday 20th April 2018 as confirmation that you have received and understood this Recall Action.

Device

ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Med...
  • 모델명 / 제조번호(시리얼번호)
    ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Medical Device (IVD)Catalogue Number: SMN 10312270Lot Numbers: 74264,73839, 57211Expiration Date: 31/7/19 ARTG Number: 184207(Siemens Healthcare - Haematology full blood count IVDs)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd