Events

Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devices 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-2018-RN-00002-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00002-1
  • 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 diagnostics have been made aware of issues regarding leaking and sticking reagent dispensers that may lead to the incomplete dispensing of a reagent required for the staining reaction. this in turn could result in light or absent staining, which without any mitigations, could cause a delay or an error in diagnosis.
  • 조치
    The manufacturer is producing new lots and customers will be notified when corrected product is available. In the interim, affected kits may continue to be used by customers but the affected kits must only be used in conjunction with same-slide controls. These controls must be appropriate for each assay and capable of detecting false negative results. For assays that directly relate to clinical therapy decision making, it is additionally important to select a same slide positive control tissue with sufficient sensitivity to detect small decreases in intensity that may cause borderline positive cases to appear as negative.

Device

Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devices
  • 모델명 / 제조번호(시리얼번호)
    Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devicesOptiView DAB IHC Detection Kit Marial Number 06396500001Lot Number Y11625, Y15571, Y19271ultraView DAB IHC Detection KitMaterial Number 05269806001Lot Number Y09284, Y15384OptiView Amplification Kit Material Number 06396518001Lot Numbers: Y15435, Y19322Hematoxylin IIMaterial Number 05277965001Lot Numbers: Y10759, Y13938, Y17402, Y17403, Y21312, Y22561ARTG 174896 and 174922
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited