Events

EZ1 DSP Virus Kit (48). An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Qiagen 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-2018-RN-00659-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00659-1
  • 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
    Qiagen have identified that the kit lots160017650, 160017770, and 160020069 contain a non-conforming ez1 dsp virus reagent cartridge lot (reg cart virus lot160011000). in the affected reagent cartridges, the proteinase k solution in well 10 is missing, i.E. well 10 is empty. at a maximum, eight of the 48 reagent cartridges in one kit are affected. all affected reagent cartridges are on position 6 within the clamshell box.
  • 조치
    Qiagen is advising users to immediately discontinue use and dispose of kits with lots 160017650, 160017770, 160020069, and/or REAG CART LOT 160011000. Users should contact Qiagen technical service to arrange replacement.

Device

EZ1 DSP Virus Kit (48). An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    EZ1 DSP Virus Kit (48). An in vitro diagnostic medical device (IVD). Catalogue Number: 62724Lot Numbers: 160017650, 160017770 and 160020069 Corresponding Reagent Cartridge: REAG CART VIRUS (RCV)Reagent Cartridge Lot Number: 160011000ARTG Number: 211651(Qiagen Pty Ltd - General laboratory reagent and consumables IVDs)
  • Manufacturer
    Qiagen Pty Ltd

Manufacturer

Qiagen Pty Ltd