Events

Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 100 Test Kit 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 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
    20108
  • 사례 시작날짜
    2016-05-02
  • 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: Abbott Diagnostics, 5440 Patrick Henry Drive, Santa Clara, California 95054, UNITED STATES OF AMERICA
  • 원인
    Manufacturer has identified a potential for increased calibration failures prior to the expiraton date for p specific lots of architect stst high sensitive troponin-1 reagent., cstomers are instructed to either:, 1. once an alternate reagent lot is available the customer is being instructed to destroy remaining inventory of affected list.Or, 2. change the expiration date of impacted lots.
  • 조치
    Product to be destroyed

Device

Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 100 Test Kit
  • 모델명 / 제조번호(시리얼번호)
    Model: 3P25-25 and 3P25-26, Affected: Lot Nos: 6103U100 55946U100 58927U100 58927U101 63010U100
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479