PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare 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-2017-RN-00678-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-26
  • 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
    Siemens has confirmed a negative bias of approximately -20% for results obtained with dimension vista cer flex reagent cartridge when calibrating cer with specific prot 1 cal lots. prot 1 controls for cer are similarly biased. a deviation in the value assignment of the affected calibrators and controls is leading to a lower result compared to correctly assigned calibrators. patient samples with a true ceruloplasmin value of up to +20% above the lower end of the reference interval may be incorrectly found below the reference interval.
  • 조치
    Siemens has assigned correct values to those lots of calibrators and controls where sufficient material was available for a new value assignment. Siemens is providing users with the correct values for these lots and advising users that these lots can be used for determination of ceruloplasmin with the revised assigned values and acceptance ranges. Lots for which revised values have not been provided are not to be used for ceruloplasmin measurements. The customer letter is to be reviewed with the laboratory Medical Director.

Device

  • 모델명 / 제조번호(시리얼번호)
    PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)PROT 1 CALProduct Code: KC710SMN: 10469516PROT 1 CON LProduct Code: KC715SMN: 10445919PROT 1 CON MProduct Code: KC716SMN: 10445920PROT 1 CON HProduct Code: KC717SMN: 10445921Multiple Lot NumbersARTG Number: 178153
  • Manufacturer

Manufacturer