Events

Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. 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-2018-RN-00628-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00628-1
  • 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 remel europe ltd, part of thermo fisher scientific, has determined that thermo scientific remel salmonella paratyphi a-h stained suspension (r30855101) is showing granularity, upon dispensing, which may be misinterpreted as a positive result when used according to the instructions for use (ifu).
  • 조치
    Thermo Fisher Scientific is requesting users:- Inspect your stocks and remove from further use all units from the affected batch number, then complete the Facsimile Reply Form supplied with the customer letter and fax it to us so that we may arrange for a credit note to be issued. Please complete the Facsimile Reply Form even if you have no remaining stock which is subject to recall, as we require this information to reconcile this process. Any requirement for review of patient results should be determined by the laboratory director.

Device

Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. An in vitro diag...
  • 모델명 / 제조번호(시리얼번호)
    Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. An in vitro diagnostic medical device (IVD)Lot Numbers: 2184561, 2308897, 2228271, 2213610 & 2258333ARTG number: 236824(Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate agglutination reagent IVDs)Possibility of Granularity Upon Dispensing
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand