Events

PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Point Of Care Diagnostics 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-2018-RN-00254-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00254-1
  • 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
    This recall is being conducted due to the potential for loss of activity of the glucose analyte prior to the full stated shelf life (august 2018).Based on the results of internal testing, there is potential for under-recovery of the glucose analyte, and therefore, potential for lower glucose test results. this issue may result in the delay in diagnosis of diabetes. there have been no adverse events reported in conjunction with this product.
  • 조치
    Point of Care Diagnostics (PTS) is advising users to inspect stock and quarantine any remaing kits of the affected lots. Affected stock is to be destroyed. PTS will issue replacement product or a credit note.

Device

PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD)Reference Number: 1765Lot Number: A705 and A707Expiry Date: August 2018Unique Device Identification Code: Lot Numbers: A705: (01)00381931765016(17)180813(10)A705Lot Numbers: A707: (01)00381931765016(17)180828(10)A707ARTG Number: 252292(Point Of Care Diagnostics Australia - Clinical chemistry substrate IVDs)
  • Manufacturer
    Point Of Care Diagnostics Australia Pty Ltd

Manufacturer

Point Of Care Diagnostics Australia Pty Ltd