Events

Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER-AW endoscope reprocessing cycle) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Saraya Australia 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-2017-RN-00139-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00139-1
  • 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
    During storage the acecide test strips may have been stored outside the manufacturer recommended 2-8°c for longer than 14 days. as a result, the shelf life of the test strips may be affected. use of test strips that have not been stored according to the recommended conditions may alert users to change the acecide solution more often than required.
  • 조치
    Customers are advised to check their inventory, quarantine, and dispose of any acecide test strips within their control. They will be provided with replacement stock for any affected inventory. Customers are also advised to ensure that the test strips must be stored between 2-8°C and that the test strip be used only after being brought to room temperature. This action has been closed-out on 01/03/2018.

Device

Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER...
  • 모델명 / 제조번호(시리얼번호)
    Acecide Test Strips(used to monitor the acecide chemical concentration as part of the Olympus OER-AW endoscope reprocessing cycle)All stock currently in the marketARTG number: 170540
  • Manufacturer
    Saraya Australia Pty Ltd

Manufacturer

Saraya Australia Pty Ltd