Events

IH-1000 with software version 04.07.02. 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-2018-RN-00245-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-03-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00245-1
  • 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
    It has been identified that when a reagent vial with an unreadable barcode is loaded on a reagents rack on ih-1000 (software version 04.07.02) and a test is performed, despite the fact the first reagent is correctly pipetted, the instrument will pipette from the vial with unreadable barcode for all the remaining wells. the system will add serum and continue as normal without alarm.This error happens following a specific sequence of events:1. use ih-1000 in version 04.07.022. load a reagent in a reagent rack3. the barcode on the reagent vial is not readable4. perform a test requiring the reagent with the unreadable barcode 5. validate the results through ih-com.
  • 조치
    BioRad is advising customers to restore the previous version of software 04.04.08. Users may contact Bio-Rad Laboratories to arrange for replacement software. BioRad is advising users to review previous results obtained since the installation of the affected software version. This can be done by checking the lot numbers in the daily journal in IH-Com. If the lot number does not appear do not use the test results and perform the test again.

Device

IH-1000 with software version 04.07.02. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    IH-1000 with software version 04.07.02. An in vitro diagnostic medical device (IVD)Catalogue Number: 001000ARTG Number: 184446(Bio-Rad Laboratories - Instrument/analyser IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd