VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 (used on VITROS 250/350/5, 1 FS, 4600 Chemistry Systems, VITROS 5600 Integrated System). 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-01099-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-25
  • 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 (ocd) has conformed that positively biased serum or plasma sample results may occur by up to +1.5mmol/l.
  • 조치
    OCD will replace your remaining inventory for VITROS® Na+ Slides calibrated with Lots 212 and 292. It is acceptable to use Lot 212 or 292 to calibrate VITROS® CHOL, Cl-, ECO2, and TRIG Slides until your replacement product arrives. This action has been closed-out on 01/02/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 (used on VITROS 250/350/5, 1 FS, 4600 Chemistry Systems, VITROS 5600 Integrated System). An in vitro diagnostic medical device (IVD)VITROS Chemistry Products Na+ SlidesProduct Code: 8379034Lot Numbers: GENs 7 to 13Expiry Dates: 01/11/2013 to 01/01/2015VITROS Chemistry Products Calibrator Kit 2Product Code: 1662659Lot Numbers: 212, 292Expiry Dates: 31/08/2014, 28/02/2014
  • Manufacturer

Manufacturer