Events

Oxoid Antimicrobial Susceptibility Testing Disc for Penicillin G (P1). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Thermo Fisher Scientific Australia & New Zealand 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-01149-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01149-1
  • 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
    An internal technical investigation by oxoid limited, part of thermo fisher scientific, has confirmed that oxoid antimicrobial susceptibility testing disc penicillin g (p1), ct0152b lot 1675623 may contain a small number of discs that produce variable results. not all of the lot is affected however our investigation identified that the size of the inhibition zone varied significantly with some discs producing larger than expected, unexpected or irregular zones of inhibition.Continued use of this lot could result in quality control failures, delayed results or false susceptibility reporting.
  • 조치
    End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director. This action has been closed-out on 22/08/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Disc for Penicillin G (P1). An in vitro diagnostic med...
  • 모델명 / 제조번호(시리얼번호)
    Oxoid Antimicrobial Susceptibility Testing Disc for Penicillin G (P1). An in vitro diagnostic medical device (IVD)Product Code: CT0152BLot Number: 167623ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand