Events

EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abacus dx 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-00317-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00317-1
  • 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
    A malfunction of elia intrinsic factor well has been discovered in elia intrinsic factor well lot 0015. a customer complaint reported erroneous test results on one single carrier of elia intrinsic factor well (14-5668-01) lot 0015. internal investigation by phadia ab indicated that no antigen solution was dispensed during elia well coating for a part of the lot. the described problem could cause erroneous test results. an erroneous test result means that the reported value will be lower than the real value for the patient sample tested, causing false negative results.To date, there have been no reports of patient injury as a result of this issue. no other lots of elia intrinsic factor well are affected.
  • 조치
    Abacus is advising customers to inspect stock immediately and quarantine any stock of Lot # 0015 to prevent further use. Customers should record the quantity in quarantine on the Customer Reply Form provided with the Customer Letter. Once the form is returned, Abacus will provide users with instructions to destroy or return the quarantined product.

Device

EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)Catalogue Number: PU14566801Lot number: 0015Expiry date: 31/01/2019ARTG: 229585Abacus dx - Clinical chemistry autoimmune IVDs
  • Manufacturer
    Abacus dx Pty Ltd

Manufacturer

Abacus dx Pty Ltd