Reagent Red Blood Cells 0.8% Resolve Panel C. 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-01599-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-12-13
  • 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 (ortho) has received an increase in customer complaints and has confirmed the intermittent presence of marked haemolysis in ortho reagent red blood cell (rrbc) products as well as quality control products containing red blood cells. ortho conducted an extensive investigation, and the root cause for the marked haemolysis, has been identified as microbial contamination. there is a single lot of one product affected in australia, reagent red blood cells 0.8% resolve panel c.If markedly haemolysed red cell products are used in testing, erroneous (false positive or false negative) results may be generated, which can potentially lead to patient harm. to date, ortho has received no reports of erroneous patient/donor results due to this issue.
  • 조치
    OCD is advising users to visually inspect all products prior to use and, as per the instructions for use, do not use red cell products if marked haemolysis or evidence of contamination is observed. If the product has marked haemolysis, contact Ortho Care Technical Solutions Center to report the issue so that the product can be replaced or credited. This action has been closed-out on 26/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).Product Code: 6902319Lot Number: VRC226Expiry: 3 January 2017ARTG Number: 254792
  • Manufacturer

Manufacturer