Events

Elecsys Beta-CrossLaps. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty Limited 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-00388-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-05-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00388-1
  • 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
    Roche is revising the package insert claims for the sample stability (serum and heparinised plasma) and biotin interference of elecsys beta-crosslaps. the package insert will be updated to reflect the results of recent internal testing for sample stability testing and biotin interference as follows:- the sample stability claim for serum kept at 20-25 degrees celcius will be revised from 8 hours to 6 hours- the sample stability claim for heparinised plasma kept at 20-25 degrees celcius will be revised from 24 hours to 4 hours- the sample stability claim for heparinised plasma kept at 4-8 degrees celcius will be revised from 24 hours to 8 hours. - the biotin interference claim "the assay should be unaffected by biotin up to 368nmol/l or 90 ng/ml" will be revised to "the assay should be unaffected by biotin up to 123nmol/l or 30ng/ml".
  • 조치
    Roche Diagnostics are providing updated information that reflects the results of recent internal testing. A package insert update will include these changes from August, 2013.

Device

Elecsys Beta-CrossLaps. An in vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited