ACL Top Family of instruments (haemostasis testing systems). An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Werfen 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-2014-RN-00633-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-06-25
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    There is potential for a sample misidentification on the acl top family that only occurs following a specific set of steps combined with the inability of the system to read a specific sample rack barcode.
  • 조치
    Werfen Australia is providing work around instructions to follow to mitigate the issue. A software update to correct the issue is in development and will be implemented once completed. This action has been closed-out on 11/02/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    ACL Top Family of instruments (haemostasis testing systems). An in vitro diagnostic medical device (IVD). ACL TOP Part Number: 00000280000 ACL TOP CTS Part Number: 00000280020 ACL TOP 700 Part Number: 00000280010 ACL TOP 700 CTS Part Number: 00000280050 ACL TOP 700 LAS Part Number: 00000280030 ACL TOP 500 CTS Part Number: 00000280040 ACL TOP 300 CTS Part Number: 00000280060
  • 의료기기 분류등급
  • Manufacturer

Manufacturer