Events

Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Assays 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-2014-RN-01350-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-12-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01350-1
  • 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
    N-acetyl cysteine (nac), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been recently determined to interfere with the detection of the following analytes on beckman coulter clinical chemistry platforms: enzymatic creatinine, cholesterol, uric acid, lactate, and lipase. nac is an anti-oxidant and can interfere with assays and this may lead to falsely low results and subsequent mistreatment.
  • 조치
    The instructions for use will be amended to contain a warning pertaining to patients being treated with N-Acetyl Cysteine (NAC) for a paracetamol overdose may generate false low results for specific tests. This action has been closed-out on 26/08/2016.

Device

Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Assays
  • 모델명 / 제조번호(시리얼번호)
    Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase AssaysEnzymatic Creatinine Reference Number: OSR6X204Cholesterol Reference Number: OSR6X16Uric Acid Reference Number: OSR6X98Lactate Reference Number: OSR6X93Lipase Reference Number: OSR6X30All lot numbers affected ARTG Number: 200018In Vitro Diagnostic Medical Devices (IVDs)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd