PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 analyser. An in vitro diagnostic medical device (IVD). 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-2016-RN-01623-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-12-15
  • 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
    The barcode and value sheet for a single lot of precicontrol varia contain an erroneous target value for control level 2, when used with certain lots of elecsys pth assay on cobas e 411 analyser. the deviation between the correct & erroneous value is 20% for pth lot 185000 & 31% for pth lot 143251. this issue can be detected because it will cause elevated level 2 control recoveries. also it can be detected if both control levels 1 & 2 are run prior to measurement of patient samples. if only control level 2 is used and a local issue occurs in the lab where false-low pth results of -20% to -31% are obtained, the control would be within range and consequently false-low results could be reported. in an intra-operative measurement scenario, an erroneous low pth result can result in an incorrect conclusion that tumour resection was complete. in the worst case, remaining cancerous or hyperplastic tissue may be left undetected. to date, no customer complaints have been received by roche.
  • 조치
    Roche is providing users with the correct control level 2 target values for the PTH assay on an updated value sheet. The correct target value is to be manually entered by the user, noting there is a reagent lot-specific value for Elecsys PTH lot 143251 and for other lots the PTH value target value should be used as per routine operation. This action has been closed-out on 25/05/2017

Device

  • 모델명 / 제조번호(시리얼번호)
    PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 analyser. An in vitro diagnostic medical device (IVD).PreciControl Varia Material Number: 05618860190Lot Number: 18928501Elecsys PTH assayMaterial Number: 11972103122Lot Number: 185000, 143251ARTG Number: 216332
  • Manufacturer

Manufacturer