Events

DELFIA Xpress PlGF Kit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 PerkinElmer 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-00629-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00629-1
  • 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
    Perkin elmer has become aware that the stability of the plgf calibrators lot 637341 is impaired. the stability issue is limited to one lot of plgf calibrators. due to the impaired stability a decreasing trend in the signal level measured for the plgf calibrators occurs; the signal level of the plgf calibrators lot 637341 has decreased an average of 20% since release. the signal decrease results in the measured plgf concentrations for the qc controls and patient samples will be falsely high, expected increase is approximately +20%. perkin elmer investigations have identified the impaired stability of the plgf calibrators is due to an issue in the quality of a single batch of the raw material used in the manufacture of the plgf calibrators.
  • 조치
    Perkin Elmer is requesting the customers to check their inventory, immediately discontinue use and destroy all the affected DELFIA Xpress PlGF kit lots. PerkinElmer will replace all DELFIA Xpress PlGF Kits of the designated lots in the inventory. Perkin Elmer is further requesting the customers to review and repeat patient samples, if PlGF control values for completed DELFIA Xpress PlGF runs with the affected product lots are not within the established acceptance range. This action has been closed-out on 04/05/2017.

Device

DELFIA Xpress PlGF Kit
  • 모델명 / 제조번호(시리얼번호)
    DELFIA Xpress PlGF Kit Catalogue numbers: 6007-002CProduct Lot numbers: 1063782701ARTG Number: 198244
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer