Events

Streptex Rapid Latex Agglutination Test. 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-2017-RN-01059-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01059-1
  • 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 themo fisher has confirmed that extraction enzyme lots 1960420 and1960621 (contained in the product lots 1959920, 1987862 and 2106328) may provide atypical performance when used with streptex g latex reagent. false positive results may be seen within the one minute reaction time detailed in the instruction for use. continued use of these lots of extraction enzyme with g latex reagent (only) may result in incorrect results reporting.
  • 조치
    Users are to inspect stocks and remove from further use all units from the affected batch numbers. Complete the Facsimile Reply Form supplied with the customer letter and fax it to the sponsor for a credit note will be issued. Requirement for a review of patient results should be at the discretion of the laboratory director.

Device

Streptex Rapid Latex Agglutination Test. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Streptex Rapid Latex Agglutination Test. An in vitro diagnostic medical device (IVD)Product Number: R30950501Lot Numbers: 1959920, 1987862 and 2106328ARTG Number: 235676
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand