Events

Beckman Coulter Access Free T3 reagent 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Beckman Coulter Inc 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
    20295
  • 사례 시작날짜
    2016-06-21
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • 원인
    Specific lots manufactured post june 2015 of the access free t3 reagent demonstrate an upward shift in patient results., patient sample results will shift upward by approximately 10.4% across the reference interval when compared to the results generated with reagent lots manufactured prior to the june 2015 design change., additional assay performance characteristics are not affected., due to matrix differences, qc values may not demonstrate a shift.
  • 조치
    Manufacturer to issue advice regarding use

Device

Beckman Coulter Access Free T3 reagent
  • 모델명 / 제조번호(시리얼번호)
    Model: A13422, Affected: Lot Nos: multiple (all lots manufactured post June 2015)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc