Events

VITROS Performance Verifier I for unconjugated bilirubin (Bu) 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-2015-RN-00465-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00465-1
  • 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
    Investigations have been performed by ortho clinical diagnostics to investigate and address an increase in customer complaints generated for low outside the range of means pv level i results on multiple vitros bu reagent lots and multiple vitros pv lots. review of the customer complaints indicate that some customers are observing results that are outside the range of means (rom), within 0.1 mg/dl of the low end.The differences observed in bu range of means capabilities are not clinically significant and the accuracy of the patient sample results is not impacted by this situation, however there is potential for results to be delayed.
  • 조치
    New Assay Sheets containing the revised Range of Means for Bu have been made available on the VITRIOS website. This action has been closed-out on 02/05/2017.

Device

VITROS Performance Verifier I for unconjugated bilirubin (Bu)
  • 모델명 / 제조번호(시리얼번호)
    VITROS Performance Verifier I for unconjugated bilirubin (Bu)Product Code: 8067324 AUST L 25922Lot numbers: A3823, C4084, Q2961, T3161, V3297, X3569 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics