Events

Liquichek Diabetes Control 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-2017-RN-00267-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00267-1
  • 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
    Bio-rad has observed that the values for the analyte haemoglobin a1c may gradually decrease over the shelf life of certain product lots.
  • 조치
    Bio-Rad advises:- 1. Laboratory means and acceptable ranges may need to be re-established for HbA1C during the shelf life of the product; 2. Users are requested to obtain a revised copy of the Liquichek Diabetes Control package insert through the Internet at http://myeinserts.qcnet.com Discard all previous versions of the package insert for these lots of product that they may have at each location and substitute those with the revised package insert.

Device

Liquichek Diabetes Control
  • 모델명 / 제조번호(시리얼번호)
    Liquichek Diabetes ControlMaster Lot Numbers: 38530, 38540, 38530VLevels: 1, 2, 3 and MiniPakCatalogue Numbers: 171, 172, 173, 172X, 291, 292, 293, 292XARTG Number: 198363
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd