Events

Ortho Clinical Diagnostics Vitros Chemistry Product Na Slides 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Ortho-Clinical Diagnostics Inc 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
    20995
  • 사례 시작날짜
    2017-11-03
  • 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/o Quigg Partners, Level 7, 36 Brandon Street, Wellington 6011
  • 원인
    The manufacturer has identified the potential for biased results to be generated over the 10 day on-analyzer limit when using vitros na+ slide cartridges warmed between 1 1/2 to 8 hours then placed on the analyzer. the manufacturer has determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit., follow up and resolution november 2017, the manufacturer is introducing vitros electrolyte reference fluid (erf) 300 and vitros electrolyte reference fluid (erf) 800 with a revised formulation that:, 1. restores the na+ cartridge warm-up protocol to 90 minutes when taken from the refrigerator (120 minutes from the freezer) as defined in the vitros na+ slides instructions for use., 2. reformulated erf helps to reduce sources of variability (e.G., calibration variability) observed when using vitros na+ slides.
  • 조치
    Manufacturer to issue advice regarding use

Device

Ortho Clinical Diagnostics Vitros Chemistry Product Na Slides
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Generation (GEN) 1 through 6, 30 through 40, 44 through 49
  • Manufacturer
    Ortho-Clinical Diagnostics Inc

Manufacturer

Ortho-Clinical Diagnostics Inc