Events

D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories 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-01258-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01258-1
  • 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 cartridge injection counts not being updated correctly when switching between the d-10 dual short program and extended program on the d-10 haemoglobin testing system due to the incorrect configuration setting in the update kit disk.
  • 조치
    As an interim measure, users are advised to manually track the number of injections on the cartridge and monitor the QC results throughout the life of the reorder pack. Bio-Rad is replacing the affected disks with a new update disk to be used with affected Reorder Packs.

Device

D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnosti...
  • 모델명 / 제조번호(시리얼번호)
    D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnostic medical device (IVD).Catalogue Number: 220-0201Reorder Pack Lot Numbers: 2003022, 20030337, 64000331, 64000332, 64000888, 64001344, 64002239, 64002240 and 64002241Floppy Diskette Lot Numbers: AA30324, AA30339, AA30545, AA31021 AA31023, AA31056, AA31097, AA31193, AA31194 and AA31195CD-ROM Lot Numbers: BA31021, BA31023, BA31056, BA31097, BA31193, BA31194 and BA31195
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd