Events

Invitrogen HLA AllSet+ Gold SSP 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Invitrogen Corporation 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
    18824
  • 사례 시작날짜
    2015-07-09
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Life Technologies, 18-24 Botha Road, Penrose, AUCKLAND
  • 원인
    The primer mix in lane 86 (a68-03c) of specific lots of these kits was expected to produce a positive reaction with dna samples containing the a*03:20 allele. the qc comments provided with these kits have been updated to indicate the potential for a false negative reaction with the a*03:20 and like alleles. this has the potential to provide a mistype result as an a*03:01 allele.
  • 조치
    Instructions for use to be updated

Device

Invitrogen HLA AllSet+ Gold SSP
  • 모델명 / 제조번호(시리얼번호)
    Model: 54010D, Affected: Selected lots
  • Manufacturer
    Invitrogen Corporation

Manufacturer

Invitrogen Corporation