Events

Vitros Performance verifier 1 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
    18611
  • 사례 시작날짜
    2015-06-03
  • 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: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • 원인
    The manufacturer has observed a positive bias with the first slide used from a cartridge that has been stored in the slide supply. the bias has been observed with multiple fluids across multiple gens and coating of slides and across the 5,1.Fs, 4600 amd 5600 analyzer platforms. the frist slide bias may occur when a cartridge is loaded on an analyzer and is not used for approximately 5-14 days., ocd has revised the range of means for vitros performance verifier1 for unconjugated biirubin (bu) only.
  • 조치
    Manufacturer to issue advice regarding use

Device

Vitros Performance verifier 1
  • 모델명 / 제조번호(시리얼번호)
    Model: 8067324, Affected: Lot Numbers: A3823 C4084 Q2961 T3161 V3297 and X3569
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479