Events

VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics Australia Pty Ltd 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-2017-RN-00361-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00361-1
  • 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
    It has been confirmed that some lots of vitros nt-probnp reagent packs exhibited the potential for an increased frequency of calibration failures, with an unexpected increase in signal for the level 1 calibrator, potentially causing a failure of the calibration parameters. preliminary testing has indicated that the calibration failure is related to a component of the vitros nt-probnp reagent pack and is not associated with the vitros nt-probnp calibrators. please note that investigations have confirmed that the increase in signal does not affect sample results (i.E., quality control or patient samples) within the 28 day calibration cycle.
  • 조치
    Ortho Clinical Diagnostics (Ortho) is advising users that they will be sent the revised Master Calibration data to ensure successful future calibrations. In the interim, users are requested to refer to the workaround details contained in their recall notifications. Users (of Lots 1580, 1590 and 1620) who experience this issue and who no longer wish to use the affected products can have the option of having their accounts credited for the product/s discarded.

Device

VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)Unique Device Identifier Number: 10758750002061Product Code: 6502156Lot Numbers: 1570 (exp. 22 Mar 2017), 1580 (exp. 13 Apr 2017), 1590 (exp. 27 Apr 2017) and 1620 (exp. 06 Jul 2017)ARTG Number: 245492
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd