Events

ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro Diagnostic Medical Device. 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-2015-RN-00062-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00062-1
  • 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 determined that incorrect calibrator lot values were assigned for advia chemistry systems drug calibrator i, lot 3jd018, for the advia chemistry systems phenytoin 2 (phny_2) and phenobarbital 2 (phnb_2) assays. this issue was determined to be the result of calibrator value miscalculation. calibrator lot 3jd018 has now been value assigned to align with the correct calibrator values.This poses a risk of an incorrect value of -10% being assigned for phenytoin testing and 3% for phenobarbital.Siemens considers these differences are negligible and would not be considered substantially relevant to impact clinical care in practice.
  • 조치
    Calibrator value reassignments are being provided in the Customer Letter for users to correct the problem. This action has been closed-out on 14/02/2017.

Device

ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro...
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro Diagnostic Medical Device. Lot Number: 3JD018Expiration Date: April 2015Siemens Material Number: 10376770ARTG Number: 175699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division