Events

Leica Bond Ready-to-Use ISH Kappa Probe 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 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
    19682
  • 사례 시작날짜
    2016-01-20
  • 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: Leica Microsystems Pty Ltd, New Zealand Branch, 3/33 Spartan Road, Takanini, Auckland 2105
  • 원인
    Manufacturer recently became aware that the product / detection kit combinations identified above may not provide adequate staining when used according to the ifnstructions for use (ifu). if the products are used according to their ifu with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm., bond polymer refine detection kits are intended for use with a large numberof other products and the identified kit lots function as specified except when used with the antibody and probe product codes listed in the table above.
  • 조치
    Product to be returned to supplier

Device

Leica Bond Ready-to-Use ISH Kappa Probe
  • 모델명 / 제조번호(시리얼번호)
    Model: PB0645, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479