Events

Pak Lx Assay 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Immucor Gamma 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
    21000
  • 사례 시작날짜
    2017-01-10
  • 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: Diagnostic Solutions Pty Ltd, 170 Fulham Road, Fairfield, VIC 3078, AUSTRALIA
  • 원인
    The manufacturer has identified, that the conjugate diluent included in lot # 3003658 and 3004022 has an expiration date specified on its labeling which is outside that supported by the stability data. the expiration date for the conjugate diluent should be one year shorter than that provided on the labels.
  • 조치
    Manufacturer to issue advice regarding use

Device

Pak Lx Assay
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Lot # 3003658 and 3004022
  • Manufacturer
    Immucor Gamma

Manufacturer

Immucor Gamma