Events

IH-1000 Immunohaemotology Analyser. 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-00456-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-05-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00456-1
  • 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
    An error relative to the liquid reagents management (test cells or anti-serum vials) might occur if the following conditions are present:1. ih-1000 is in status “ready to start” and:2. the user requests the unloading of a reagent rack while the system is creating the internal batch (the time slot during which the error could occur is about 2 seconds);3. another is loaded immediately afterwards in the same position.If all three conditions are present, the ih-1000 may not use the full set of liquid reagents required to perform the tests of the ongoing batch.Due to a software failure, the system may only use the vial placed in the first position of the re-loaded rack for all the tests of the ongoing batch.
  • 조치
    Bio-Rad is providing end users with work around instructions to mitigate the risk of incorrect results. A permanent correction will be made in the next software update.

Device

IH-1000 Immunohaemotology Analyser. An in vitro Diagnostic Medical Device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    IH-1000 Immunohaemotology Analyser. An in vitro Diagnostic Medical Device (IVD)Product REF: 001000All software versionsARTG number: 184446
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd