VaccZyme Anti-Haemophilus Influenzae B Kit Code: MK016 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 In Vitro Technologies 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-2015-RN-00086-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-02-10
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Possible visible and/or sub-visible microbial contamination of sample diluent was identified following a customer notification. internal testing has shown filtration of sample diluent using a 0.2 micron filter does not cause any significant change in performance of the diluent and therefore may be employed by the customer.
  • 조치
    Internal testing by The Binding Site has shown that filtration of the sample diluent using a 0.2 micron filter does not cause any significant change in the performance of the diluent and therefore may be employed by the customer to remove the physical matter that may be present. It is strongly recommended that the filter and any alternative receptacles used are both as clean as possible in order to prevent any further potential for contamination of the product. This action has been closed-out on 03/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    VaccZyme Anti-Haemophilus Influenzae B Kit Code: MK016Lot Numbers: 341492, 347294
  • Manufacturer

Manufacturer