Events

VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS Systems). 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-2015-RN-00974-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-10-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00974-1
  • 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
    There is a potential for an increase in u90-382 or 6lu condition codes (wash errors) when using vitros calibrator kit 9, lot 0954.The increase in u90-382 and 6lu condition codes primarily occurs when using vitros dgxn and phyt slides. vitros acet and crbm slides are not affected. when the u90-382 or 6lu condition code occurs, the vitros system suppresses the result and no result is reported. all numerical results obtained are valid providing that no wash errors occurred and quality control results were within acceptable limits.
  • 조치
    OCD is advising users to discontinue use and discard all remaining inventory of the affect lot. OCD will replace the affected units or provide a suitable credit. The affected lot may still be used until replacement lots are available. This action has been closed-out on 06/09/2016.

Device

VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS System...
  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS Systems). An in vitro diagnostic medical device (IVD).Product code: 8568040Lot Number: 0954Expiry Date: 31 May 2016Unique Device Identifier Number: 10758750005031ARTG number: 245278
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics