Events

Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identification of Shigella dysenteriae). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Oxoid 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-2014-RN-00868-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00868-1
  • 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
    An internal technical investigation by the manufacturer has identified that the listed lot numbers of shigella dysenteriae polyvalent (1-10) agglutinating serum may react with negative isolates, resulting in false positive results.
  • 조치
    Oxoid Australia Pty Ltd is recalling the affected batches of product. End users are requested to inspect their stocks and remove from further use all units from the above lot numbers. The requirement for review of patient results should be determined by the laboratory director. This action has been closed-out on 03/06/2016.

Device

Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identifica...
  • 모델명 / 제조번호(시리얼번호)
    Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identification of Shigella dysenteriae). An in vitro diagnostic medical device (IVD)Product Code: R30163701Carton Lot Number: 1111470Bottle Lot Number: 1130078Carton Lot Number: 1236726Bottle Lot Number: 1297592
  • Manufacturer
    Oxoid Australia Pty Ltd

Manufacturer

Oxoid Australia Pty Ltd