Events

Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Shanahan Consulting 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-2012-RN-00789-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-08-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00789-3
  • 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
    Anomalous decreases in the average optical density (od) have been observed with certain kits within the lifecodes pak product line. the decrease in od was caused by a chemical reaction with an unknown compound that was introduced into the manufacturing process when faulty vials supplied by a third party were used to contain the substrate buffer kit component.
  • 조치
    Quarantine and discard affect products. The sponsor recommends reviewing past valid assay runs and compare Positive Control values obtained with recalled kits against historical trend data and discussing results with healthcare providers to determine if any further testing is required.

Device

Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. An in vitro diagnostic medi...
  • 모델명 / 제조번호(시리얼번호)
    Substrate buffer used with LIFECODES PAK12 and LIFECODES PF4IgG Kits. An in vitro diagnostic medical device (IVD)Substrate buffer Lot Number: SB092011used with:LIFECODES PAK12Catalog Number: PAK12Kit Lot Number: 101911P12LIFECODES PF4IgG KitsCatalog Number: HAT45GKit Lot Number: 100311H45G
  • Manufacturer
    Shanahan Consulting Pty Ltd

Manufacturer

Shanahan Consulting Pty Ltd
  • Source
    DHTGA