Events

VerifyNow Aspirin Test Kit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 In Vitro Technologies 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-2015-RN-01252-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01252-1
  • 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 limited number of kits may result in excessive sample leakage out of the test device cartridge. if this occurs, the verifynow performance results are not affected as the leakage occurs "downstream" of where the reaction occurs and operators are protected by the universal precautions for blood products; however, the instrument can potentially be affected.
  • 조치
    In Vitro Technologies is advising users to inspect stock and quarantine affected batches for return and replacement with unaffected stock. In Vitro Technologies is advising users to perform a EQC test. This action has been closed-out on 04/05/2017.

Device

VerifyNow Aspirin Test Kit
  • 모델명 / 제조번호(시리얼번호)
    VerifyNow Aspirin Test KitItem Number: ACD85053Lot Number : WH0204ARTG Number: 215577 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd