Events

Iris iChem Velocity Chemistry Strips 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Iris International 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
    19061
  • 사례 시작날짜
    2015-10-02
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • 원인
    The manufacturer has become aware of a manufacturing defect where a glucose pad was placed in the location intended for the protein pad on a subset of vials numbered 14996 through 15859 (with the exception of vials 15315 and 15316 within that series) within lot number 7204081a. the hazarous situation is false negative or false positive urine protein for patient samples released to the physician.
  • 조치
    Product to be destroyed

Device

Iris iChem Velocity Chemistry Strips
  • 모델명 / 제조번호(시리얼번호)
    Model: 800-7204, Affected: Lot: 7204081A
  • Manufacturer
    Iris International

Manufacturer

Iris International