Events

PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 Lot No. 174801 & 174801(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.) 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-00957-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-09-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00957-1
  • 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
    Roche has received a number of complaints that the recovery of c-reactive protein gen. 3 (crpl3) was too high in precicontrol clinchem multi 1 (pccc1), and especially in precicontrol clinchem multi 2 (pccc2), seen mainly on the cobas c 501 module. roche diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. to resolve this issue a revised target value assignment procedure was necessary. target values for currently available pccc1 and pccc2 control lots have been adjusted – as per the tables given in the customer letter.
  • 조치
    Target values for currently available PCCC1 and PCCC2 control lots have been adjusted – as per the tables given in the Customer Letter. Users are requested to use these revised values. This action has been closed-out on 04/03/2016.

Device

PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 ...
  • 모델명 / 제조번호(시리얼번호)
    PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 Lot No. 174801 & 174801(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.)ARTG number: 216332
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited