Events

CIDEX OPA Solution Test Strips 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical 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-00298-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-04-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00298-1
  • 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
    The manufacturer has determined that shelf life data for the cidex opa solution test strips is effective for only 10 months of the test strip’s labeled 12-month shelf life. there is no potential risk to patient safety, as test strips used at the end of shelf life would indicate a false negative (e.G. “fail” result for solution above the minimum effective concentration). this issue could be observed during either qc testing of the test strips prior to use (in accordance with the instructions for use) or during testing of cidex opa solution when the test strips are near the end of shelf life. there was no evidence that a false positive (e.G. a “pass” result for solutions below the mec) would occur.A corrective action is in place to update the shelf life of the cidex® opa solution test strips from 12 months to 10 months.
  • 조치
    Customers are requested to update the expiry date from 12 to 10 months. This action has been closed-out on 03/03/2016.

Device

CIDEX OPA Solution Test Strips

Manufacturer

Johnson & Johnson Medical Pty Ltd