Events

ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (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-2013-RN-00778-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-07-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00778-1
  • 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 has confirmed that a portion of folate readypacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (qc) and patient results. if the calibration and qc on a readypack are valid, results generated with this readypack are not affected. however, due to the sporadic nature of the issue, successful calibration and qc on one readypack may not reflect acceptable performance of other readypacks in the lot.
  • 조치
    If a customer has an alternative method or lot of ADVIA Centaur Folate, Siemens Healthcare is advising users to transition all folate testing to the alternative lot or method. Siemens Healthcare is providing users with work around instructions to follow with the affected product. The Laboratory Medical Director should determine if repeat testing of patient samples that demonstrated results below the reference interval is appropriate.

Device

ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (an in vitro diagnostic medical device (IVD))
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (an in vitro diagnostic medical device (IVD))ADVIA Centaur Folate (100 tests)Kit Lot Numbers: 22288218, 22296218 & 22907218ADVIA Centaur Folate (500 tests)Kit Lot Numbers: 22289218, 22297218 & 22535218ADVIA Centaur Folate (500 tests)Kit Lot Number: 22298218ADVIA Centaur Folate (2500 tests)Kit Lot Number: 22299218Expiration Date: 17 Feb 2014ARTG Number:175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division