LEUKOSURE ENUMERATION KIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 BECKMAN COULTER CANADA L.P. 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
    69169
  • 사례 위험등급
    II
  • 사례 시작날짜
    2010-06-07
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    There is incorrect activity levels stated on the instructions for use labeling in the leukosure enumeration kit due to the inaccurate activity values provided by the supplier for the raw material ribo-nuclease a type iii-a utilized as a component of the leukosure stain reagent. the activity value for these lots is 3.25ku/ml as compared to 4ku/ml as stated in the product labeling. alteration of the staining enumeration of white blood cells (wbc) in blood component preparation might produce falsely high values of white blood cells in samples with high levels of residual rna. these high values may result in the the blood component being considered inappropriate for use in transfusions thereby reducing the availability of blood for transfusion procedures. the high values may also result in unnecessary reprocessing of the blood component.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 175621 (Lot serial: 5621013K); Model Catalog: 175621 (Lot serial: 5621012K); Model Catalog: 175621 (Lot serial: 5621014K)
  • 제품 설명
    LEUKOSURE ENUMERATION KIT
  • Manufacturer

Manufacturer