VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems, Software Versions 3.1 & Below 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-2014-RN-01251-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-28
  • 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 investigation has determined that the software may not properly identify an expired calibration. calibration status is monitored by the system software which is based upon the calibration interval and the date of the last calibration. if the anomaly occurs, a calibration may expire, but the system may not alert the operator and not flag results with a ce sample result code (i.E., calibration expired). the system may unexpectedly generate results even though it is configured to not report results when a calibration has expired the anomaly may potentially occur on any type of assay processed on the systemif an expired calibration occurs for an assay and is not detected by the operator, samples may be processed without a valid calibration. however, quality control fluids would be processed at the next routinely scheduled time period. if quality control results were acceptable, patient results obtained prior to that time would not have been adversely affected.
  • 조치
    The resolution to this anomaly will be contained in the next version of software currently under development. Until the new software is installed on the affected VITROS System, users are advised to use the “All Assay Data” option instead of “Load New Lots" when installing Assay Data Diskettes (ADDs) on the system. If any of the calibrations are expired, the system will post PZB-005 condition codes. Perform calibrations prior to using those reagents. Users are also advised to discuss any concerns that may have regarding previously reported results with their Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 12/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems, Software Versions 3.1 & BelowSystem Product Codes: 6802783, 6802445, 6802413ARTG Number: 180199
  • Manufacturer

Manufacturer