Events

VITROS Chemistry Products HPT Reagent. 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-2012-RN-01143-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01143-1
  • 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
    Customers have reported the inability to calibrate vitros hpt reagent due to an increase in "u91-274" condition codes. in cases of successful calibration, some customers have also reported an increase in "u91-274" condition codes that prevented results when processing patient samples and quality control fluids. a potential for biased results exists if the user is able to obtain a valid calibration and quality control (qc) may not detect the issue.
  • 조치
    Discontinue and discard remaining inventory of VITROS HPT Reagent. Ortho-Clinical Diagnostics recommends discussing previously reported results with the Laboratory Director to determine the appropriate course of action.

Device

VITROS Chemistry Products HPT Reagent. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products HPT Reagent. An in vitro diagnostic medical device (IVD)Product code: 6802214Lot number: 1533-19-2133 (Assay identifier 1533, GEN 19, Lot 2133); Expiration date: 20 Nov 2012Lot Number: 1533-20-2314 (Assay identifier 1533, GEN 20, Lot 2314); Expiration date: 11 Feb 2012
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics