Events

VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). 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-2016-RN-01376-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-10-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01376-1
  • 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
    Ortho clinical diagnostics has confirmed that some barcode labels included in some vitros calibrator kit 25, lot 2576 cartons contain an incorrect lot number. the labels indicate lot 2575 instead of the correct lot 2576 for all three calibrator levels. the printed barcode labels are used with the automatic calibration feature when calibrating vitros 4600 or 5600 systems. when the operator attempts to use the affected barcode labels to calibrate vitros dhdl slides, a ‘pzc-006’ condition code occurs, indicating that the calibrator lot is not supported by the assay data disk (add); therefore the calibration is not successful. all labelling on the calibrator vials and the carton is correct. lot 2576 calibrators perform as expected if the operator manually programs the correct lot information for calibration.
  • 조치
    Ortho is advising users to inspect the barcode labels provided in VITROS Calibrator Kit 25, Lot 2576, discard affected labels that indicate Lot 2575, and to manually program Lot 2576 when calibrating VITROS dHDL Slides.

Device

VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Che...
  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). An in vitro diagnostic medical device (IVD).Product Code: 6801896Lot Number: 2576Expiry Date: 02 Sept 2017ARTG Number: 232248
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd