Events

Tina-quant Soluble Transferrin Receptor (STFR): Elevated imprecision with QC Level 1 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty Limited 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-00499-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00499-1
  • 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
    Stfr reagent lots# 606453 and 606449 may show elevated imprecision and possible high recovery of stfr control set level 1. this issue can lead to a bias in the stfr results (max + 11%, min-15.1%) in patient samples.In case of erroneous high stfr results, unnecessary further examination of erythropoesis and iron status are possible. however, no treatment decision should be based on stfr values alone. medical history, further findings and other parameters such as transferrin, reticulocyte count, iron, hb, heamatocrit, mcv, ldh, ferritin should be taken into account. in case of the erroneous low/normal results a delay in differential diagnosis of anaemic condition cannot be excluded.
  • 조치
    Roche Diagnostics is requesting their customers to discontinue use of Tina quant Soluble Transferrin Receptor (STFR) Lot# 606453 and Tina quant Soluble Transferrin Receptor (STFR) Lot # 606449. Replacement will be sent to laboratories free of charge. This action has been closed-out on 17/08/2016.

Device

Tina-quant Soluble Transferrin Receptor (STFR): Elevated imprecision with QC Level 1
  • 모델명 / 제조번호(시리얼번호)
    Tina-quant Soluble Transferrin Receptor (STFR): Elevated imprecision with QC Level 1ARTG Number: 174908
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited