Events

Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitro diagnostic medical device (IVD)(for use with the Access family of immunoassay systems) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter Australia Pty Ltd 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-2017-RN-00679-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00679-1
  • 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
    Beckman coulter has determined through customer feedback and an internal investigation that the four (4) access immunoassays listed are susceptible to biotin interference. during interference testing, the interference occurred with samples that contained 100 ng/ml of biotin. this level of biotin is greater than the maximum biotin concentration observed in the normal healthy population.Specimens from patients who are undergoing biotin therapy and/or ingesting biotin supplements may contain high levels of biotin. the higher biotin concentration in these specimens interferes with the biotin-streptavidin assay design of these four affected access assays and may cause false low results (for the access gi monitor and thyroglobulin assays) and false high results (for the access free t4 and total t3 assays).
  • 조치
    Beckman Coulter will update the "Limitations" section of the Access Total T3, Thyroglobulin, Free T4, and GI Monitor Instructions for Use with this biotin interference information. Users are requested to interpret the results in light of the total clinical presentation of the patient (including symptoms, clinical history, data from additional tests, and other appropriate information).

Device

Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitr...
  • 모델명 / 제조번호(시리얼번호)
    Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitro diagnostic medical device (IVD)(for use with the Access family of immunoassay systems)Access Total 3Reference Number: 33830Access ThyroglobulinReference Number: 33860Access Free T4Reference Number: 33880Access GI MonitorReference Number: 387687All LotsARTG Numbers: 213975 and 213976
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd