Events

ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abacus ALS 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-2016-RN-00014-2
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-01-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00014-2
  • 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
    The ranges for mean concentration of igg/igg4 stated on the vial label of the quality control sample are incorrect. the new measuring ranges for immunocap specific igg/igg4 i1 control h, all lots when used in combination with immunocap i1, lot 389b7 and 389b8 are:igg4: 12 – 25 mg/ligg: 24 - 47 mg/lthe problem can be detected by the operator since the quality control samples will fail.
  • 조치
    The sponsor is advising users to use the following new measuring ranges for ImmunoCAP Specific IgG/IgG4 i1 Control H: IgG4: 12 – 25 mg/l IgG: 24 - 47 mg/l Patient results are not affected. No action needs to be taken in regards to past or current patient results for ImmunoCAP Allergen i1, Honey bee venom.

Device

ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)Part Number: 10-9475-01Lot Numbers: All lot numbers when used in combination with ImmunoCAP Allergen i1Honey bee venom art. No 14-4143-01, lot numbers 389B7 and 389B8ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd