Events

Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. 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-00577-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00577-1
  • 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
    There is a possibility that drug interferences from administration of metamizole (dipyrone) to patients may generate false low results. metamizole (dipyrone) has been identified as an interferent which may cause false low results in certain assays. this is a previously undocumented interferent.These interferences are based on a chemical interaction with the trinder reaction, similar to nac interference previously identified by beckman coulter and may result in an error in diagnosis or patient management.No customer complaints have been received for this particular issue.
  • 조치
    Beckman Coulter is providing users with updated Instructions for Use (IFU) to follow in order to avoid any potential interferences. A review of previously generated patients results is at the discretion of the Laboratory Director.

Device

Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. A...
  • 모델명 / 제조번호(시리얼번호)
    Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. An in vitro diagnostic medical device (IVD)Product Codes: OSR6X204, OSR6X16, OSR6X118, OSR6X98, OSR6X93, OSR6X30All lot numbers affectedARTG Numbers: 200018, 200015
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd