Events

Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. An in vitro diagnostic medical device (IVD) 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-01257-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01257-1
  • 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, inc. (ocd) has determined that the default dilution factors on the calibration diskette (cal disk) and assay data disks (add), drv 5740 and below, are incorrect. it has also been determined that the 2nd dilution factors contained in the engen laboratory automation system configuration (.Gsb) file (version 3.2.2 & below) are incorrect.
  • 조치
    Ortho-Clincial Diagnostics is providing their customers with Local Cal Disk or ADD version 5741 which contains the correct dilution factors. Customers are also advised to review their LIS data to determine the impact of the revised default dilution factors. For those customers using the enGen system, an Ortho-Clinical Diagnostics representative will assist in the development of revised dilution factors. This action has been closed-out on 12/02/2016.

Device

Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. An in vitro dia...
  • 모델명 / 제조번호(시리얼번호)
    Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. An in vitro diagnostic medical device (IVD)VITROS Chemistry Instruments: -VITROS 4600-VITROS 5600-VITROS 250-VITROS 350-VITROS 5,1 FS-enGen systemVITROS Chemistry Products:ALT slides -1655281 CK slides -8479396, -8478034LDH slides -8384489 hsCRP reagent -6801739 THC reagent -6801994 TIBC kit -8867541 METD reagent -6801996 CRBM slides -8892382
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics