Events

Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical device 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-2018-RN-00023-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00023-1
  • 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 issue has been found with the stability of immunocap allergen c5, ampicilloyl and immunocap allergen c6, amoxicilloyl. an internal monitoring real time stability study determined that the stability specifications were not met. the products have a nominal 12 months shelf life stated on the label.The reduced stability may result in erroneous test results for affected lot numbers.No other immunocap tests are affected by this issue. no adverse events have been reported to date.
  • 조치
    Abacus is advising customers to discard any unused product. New product is expected to be available in Q3 2018. A review of previous results reported below the assay Limit of Quantification is advised.

Device

Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medi...
  • 모델명 / 제조번호(시리얼번호)
    Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical deviceMaterial Numbers: 14-4450-01 and 14-4451-01Multiple Affected Lot NumbersARTG: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd