Events

ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. An in vitro diagnostic medical 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-01496-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-11-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01496-1
  • 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
    For particular lot combinations of immunocap specific igg/igg4 i1 control h and immunocap allergen i1, honey bee venom, the ranges for mean concentrations of igg and igg4 stated on the vial label of the quality control sample are incorrect. the problem can be detected by the operator as the quality control samples will fail. the issue affects the immunocap specific igg/igg4 i1 control h samples only; patient results for i1 are not affected by the lot number of immunocap allergen i1, honey bee venom, used to generate the assay result. the correct measuring ranges for the quality control are being provided.
  • 조치
    Abacus ALS is providing users with the correct measuring ranges for ImmunoCAP Specific IgG/IgG4 i1 Control H, vial lots with expiry date until July 2017 (C6XAX or older), when used in combination with ImmunoCAP i1, lots 389B7, 389B8, 389B9, 389BA & 389BB. The correct ranges are: IgG4: 12 – 25 mg/l and IgG: 24 - 47 mg/l. No action needs to be taken in regards to past or current patient results for ImmunoCAP Allergen i1, Honey bee venom. This action has been closed out on 15 June 2017.

Device

ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. A...
  • 모델명 / 제조번호(시리얼번호)
    ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. An in vitro diagnostic medical device (IVD).ImmunoCAP Specific IgG/IgG4 i1 Control HArticle Number: 10-9475-01Vial Lots: with expiry date up to July 2017 (C6XAX or older)ImmunoCAP Allergen i1, Honey bee venomArticle Number: 10-4143-01Lot Numbers: 389B7, 389B8, 389B9, 389BA & 389BB ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd