Events

ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). An in vitro diagnostic medical device (IVD). 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-00598-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00598-1
  • 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 is issuing a field correction for a change in the concentration of n-acetylcysteine (nac) that may cause interference for the advia chemistry systems acetaminophen assay current lots and all future lots. the previous maximum nac concentration at which acceptable acetaminophen results were obtained was 800 mg/l. siemens has revised the concentration of nac at which acceptable results were obtained to 200 mg/l nac in an acetaminophen sample of approximately 661 µmol/l (10 mg/dl).
  • 조치
    Siemens is advising end users of the change in the instructions for use regarding interference caused by NAC. The Instructions For Use (IFU) will be updated to reflect this change in interference.

Device

ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). An in vitro diagnostic medical de...
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). An in vitro diagnostic medical device (IVD).Catalogue/Lot number – SMN 10327381, all current lots (see below) and all future lotsCurrent lots - 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157, 47558ARTG Number: 176646
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division