Events

Wallac Panthera-Puncher 9 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 PerkinElmer 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
    16956
  • 사례 시작날짜
    2014-07-14
  • 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: SciMed Ltd, Unit 2, 1 Tussock Lane, Ferrymead, Christchurch 8023
  • 원인
    Wallac oy, a subsidiary of perkinelmer, has become aware that extended exposure to the ioniser pins of the panthera-puncher 9 can decrease the reaction signal level of assays using antibody coated microtiter plates (such as immunoassays). wallac oy's investigation has shown that uncoated plates are not affected by the phenomenon (such as enzymatic assays). the phenomenon has been determined to be localised to those wells that are located beneath or adjacent to the ioniser pins when the panthera-puncher 9 is idle or in sleep mode. the software allows the ioniser to remain active when the puncher is idle or has gone into sleep mode. the impact on health is dependent on the assay and the associated disorder the assay screens for in the dried blood spot sample.
  • 조치
    Product to be modified

Device

Wallac Panthera-Puncher 9
  • 모델명 / 제조번호(시리얼번호)
    Model: Catalogue Number: 2081-0010, Affected:
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer