Events

Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD). 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-2017-RN-00159-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00159-1
  • 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 australia has received several reports that lysercell wdf 2 x 4l lots a6028, a6029 and a6030 can lead to an increased occurrence (up to 3-fold) of the flag “blast/abn lympho?” . no other flags have been observed. this issue leads to an increase in the “blast/abn lympho?” flagging rate and unnecessary manual review. the risk of a misdiagnosis is mitigated by the fact that any flags observed from the affected instruments must be confirmed by a qualified morphologist using a manual blood film.
  • 조치
    Roche is advising customers to immediately discontinue use of and quarantine affected lots. New replacement lots will be provided by Roche.

Device

Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagno...
  • 모델명 / 제조번호(시리얼번호)
    Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD).Material Number: 06510221001Lot Numbers: A6028, A6029, A6030ARTG Number: 188498
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited