Ortho Clinical Diagnostics BioVue System Cassettes 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Ortho-Clinical Diagnostics European Support Centre 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
    15059
  • 사례 시작날짜
    2013-08-08
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 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: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • 원인
    Ortho clinical diagnostics (ocd) has identified isolated occurrences of improperly positioned cassette labels for the products specified. the use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection results. there is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent.
  • 조치
    Product to be exchanged

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: BioVue ABD confirmation Cassette, VioVue Rh/K Cassette, BioVue ABO-DD Grouping Cassette, BioVue ABO-Rh Grouping Cassette, BioVue Poly/Neutral Cassette, Affected: Lots: 6904485 and 707135
  • Manufacturer

Manufacturer