Events

Anti-dsDNA Kit. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Immuno 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-2014-RN-01362-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-12-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01362-1
  • 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
    Specific product codes for the anti-dsdna kit (used to test for antibodies to dsdna), were omitted in error from the packaging material. customers have received the correct products, however due to the omission of the product code on the outer box it is not clearly identifiable if they have received the 50 tests version (im77 lot c323026) or 100 tests version (im771 lot c323027). the kits can be differentiated by the lot numbers printed on the outer box. please note that the individual component labelling within the kit has not been affected.The tracer and ammonium sulphate solution lot numbers were omitted for these particular lots of product listed above.
  • 조치
    A set of labels (stickers) will be provided to customers to place over the existing directions that will correct the problem. The Customer Letter contains detailed instructions on where to place the stickers – including examples in the form of pictures. This action has been closed-out on 02/03/2016.

Device

Anti-dsDNA Kit. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    Anti-dsDNA Kit. An in vitro diagnostic medical device (IVD).50 Test kit Batch Number:- C323026 Product Code IM77100 Test kit Batch Number:- C323027 Product Code IM771
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA