VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quantitative measure of phenobarbital) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 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
    RC-2013-RN-00254-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-19
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Ortho clinical diagnostics has received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using vitros chemistry products phbr slides. an investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
  • 조치
    End users are requested to discard all lots of VITROS PHBR Slides. It is recommended that any concerns with previously reported patient results be discussed with the laboratory director and requesting physician.

Device

  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quantitative measure of phenobarbital)GEN 38. Coating 0060GEN 39. Coating 0062GEN 40. Coating 0063GEN 41. Coating 0064Expiry date range: 1 April 2013 through 1 February 2014
  • 의료기기 분류등급
  • Manufacturer

Manufacturer