Events

Liquichek Specialty Immunoassay Controls. 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-2016-RN-00146-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00146-1
  • 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 have observed that intact pth may not meet the thawed unopened and thawed open vial stability claims as printed in the package inserts. there is a possibility that intact pth values in the lots affected may gradually shift down due to a decrease in stability when the product is stored at 2 to 8°c. the claims for intact pth have been revised from 23 days to 7 days.Although unlikely, the reported issue may result in a delay in result reporting or the false signalling of an in-control situation.
  • 조치
    Bio-Rad is advising users not to use the control for intact PTH beyond 7 days when stored at 2 to 8°C. Users are able to obtain a revised package insert with the updated stability time frames from http://myeinsters.qcnet.com

Device

Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)Master Lot Numbers:57430, 57440, 57450, 57460, 57470, 57480, and 57490ARTG Number: 194959
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd