Events

Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Elitechgroup Australia 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-2015-RN-00331-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00331-1
  • 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
    There is a stability issue with a single component of the kit, vial 1 beta-2-microglobulin immunoparticles. investigations have shown that a change in the ph value in the beta-2-microglobulin immunoparticles (vial 1) has occurred resulting in low or no signal for the 2 lowest standards in the calibration curve. the identified change in the ph value may affect the accuracy of beta-2-microglobulin values/results obtained, without any warnings from instruments. the beta-2-microglobulin values may be measured up to 20% higher for samples in the clinically elevated ranges.
  • 조치
    ELITech Group is advising users to cease use of the affected lot and discard any remaining inventory. This action has been closed-out on 18/07/2016.

Device

Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD) Product code: K0052Lot Number: 20012249ARTG number: 200116
  • Manufacturer
    Elitechgroup Australia PTY LTD

Manufacturer

Elitechgroup Australia PTY LTD