Events

Remel Wellcolex Colour Shigella Reagent. 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-01103-1
  • 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-01103-1
  • 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 thermo fisher scientific has confirmed that specific lots of remel wellcolex colour shigella reagent may notagglutinate in the presence of positive cultures. a negative result indicates that the organisms under test do not belong to the serotypes of shigella species covered by the reagents. latex reagent 2 is used to identify common serotypes of s. dysenteriae and s. boydii. continued use of these lots may result in a failure to correctly identify s. boydii. s.Dysenteriae results are unaffected. latex reagent 1 continues to perform correctly and will identify common serotypes of s. sonnei and s. flexneri.
  • 조치
    1. Inspect your stocks and remove from further use of all units from the impacted batch number, then complete and return the Facsimile Reply Form supplied with the customer letter. 2. If any recalled stock has been transferred from your laboratory to another, inform that laboratory of the recall action.

Device

Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)Product Code: R30858401Lot Numbers: 1991413, 2130764, 2110576, and 2143554ARTG Number: 236824
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand