Events

Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Zoll Medical 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-2013-RN-01364-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01364-1
  • 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
    The manufacturer, itc has determined that citrate aptt cuvettes from the lots listed above may recover higher than expected results in normal individuals. itc’s investigation into the affected lots identified that when performing tests on non-heparinized e.G., normal blood samples, results may average higher than historic values. test results performed on patients receiving heparin therapy are not affected. itc has evaluated the risk to health using the affected device and has determined under a variety of clinical conditions, an erroneous increase in the citrated aptt baseline may contribute to serious injury.
  • 조치
    Zoll Medical Australia is requesting their customers to inspect their stock and quarantine all affected lots of the product. Zoll Medical Australia will arrange for the recovery and replacement of stock. Customers are advised that the requirement for retesting reported patient results should be discussed with the Laboratory Director.

Device

Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes. An in vitro diagnostic medical dev...

Manufacturer

Zoll Medical Australia Pty Ltd