Events

VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in vitro diagnostic 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-01547-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01547-1
  • 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 is providing additional information for a product correction notification that was issued in december 2015 (rc-2016-rn-00017-1) regarding the clarification of operator actions for wash errors. since that time, ortho has been monitoring the occurrence of u90-382 or 6lu condition codes associated with wash errors and observed that wash errors were occurring at a higher than expected rate for vitros phyt slides. it was determined that vitros systems could sometimes identify false wash errors. if a u90-382 or 6lu code is generated, the vitros system suppresses the result and “no result” is reported (and review of previously reported results is not necessary).Ortho has identified an improvement to the wash algorithm that will help reduce false wash errors while not compromising the detection of true wash errors. this improvement involves a change to the magenta wash tolerance (mwt) limit and will be implemented on calibration diskette/assay data diskettte (add) drv 5910 and above.
  • 조치
    Ortho is advising users to install Calibration Diskette or ADD DRV 5910 or above on their VITROS system. An automatic download will be available for e-Connected systems as of December 2, 2016. The Calibration Diskette and/or ADD will also be sent to the customer's facility when available. After loading DRV 5910 (or above) for the first time, VITROS PHYT Slides will un-calibrate and will require recalibration. In the interim, the product can continue to be used.

Device

VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in ...
  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in vitro diagnostic device (IVD). VITROS Chemistry Products PHYT SlidesProduct Code: 8298671 Lot Numbers: all current (in date) lotsCalibration Diskette (Product Code: 8716607) & Assay Data Diskette (ADD) (Product Code: 6801876) versions (DRV) 5909 and belowARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd