Events

Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for use on the Dimension Clinical Chemistry System. In vitro diagnostic medical devices (IVDs) 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-00153-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00153-1
  • 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 have confirmed customer complaints of falsely depressed creatinine results when ezcr is processed from open wells that are in close proximity to open wells of phos reagent. the inaccurate ezcr results are caused by a reagent interaction that occurs when vapour from phos reagent is absorbed by open wells of the excr flex reagent cartridge. both quality control (qc) samples and patient samples are affected.
  • 조치
    If both Enzymatic Creatinine and Phosphorus are tested using the instrument, customers are requested to discontinue the use of one of the tests. Customers with two or more Dimension systems should perform testing of Enzymatic Creatinine and Phosphorus on separate instruments. This action has been closed-out on 12/02/2016.

Device

Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for...
  • 모델명 / 제조번호(시리얼번호)
    Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for use on the Dimension Clinical Chemistry System. In vitro diagnostic medical devices (IVDs)PHOS Flex Reagent CartridgeCatalogue Number: DF61Material Number: 10444951EZCR Flex Reagent CartridgeCatalogue Number: DF270BMaterial Number: 10471520ARTG Number: 181686
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division