Events

Beckman Coulter Enzymatic Creatinine 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Beckman Coulter Inc 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
    20115
  • 사례 시작날짜
    2016-05-06
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • 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 the following assays: cholesterol osr6x16, triglyceride osr6x118, uric acid osr6x98, lactate osr6x93, enzymatic creatinine osr6x204 and lipase osr6x30. 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.
  • 조치
    Instructions for use to be updated

Device

Beckman Coulter Enzymatic Creatinine
  • 모델명 / 제조번호(시리얼번호)
    Model: OSR6X204, Affected:
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc