ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - BNP Ready Pack Lot 038174 (An in vitro diagnostic medical device (IVD)) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-2014-RN-01080-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-08
  • 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 healthcare diagnostics has confirmed that there may be an incorrect side label on a small percentage of the advia centaur systems bnp ready packs from reagent lot 038174. incorrectly labelled ready packs are included within kit lots 43305174, 43278174, 43306174 and 43279174. the human-readable side label may incorrectly identify the ready pack as advia centaur systems ft4 ready pack. the ready pack end label and the barcode end label correctly identify the ready pack as the advia centaur systems bnp ready pack and the ready pack will scan correctly as bnp when loaded onto the advia centaur systems. the kit boxes are correctly labelled as bnp. other advia centaur bnp kit lots ending in 174 are not impacted. the reagent in the ready pack has been verified as bnp reagent and will generate valid results when calibrating and running quality control or patient samples using the affected advia centaur systems bnp ready pack kit lots.
  • 조치
    Siemens Healthcare Diagnostics(SHD) is instructing their customers to examine their inventory of BNP Ready Packs identified with the human-readable FT4 side labels and discard any affected packs. Siemens representative will provide the product replacement. Siemens is also informing their customers that any results generated with an affected pack are valid; the instruments identify the pack correctly and there is no performance issue with the reagent within the packs. This action has been closed-out on 11/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - BNP Ready Pack Lot 038174 (An in vitro diagnostic medical device (IVD))Catalog Number: 02816138 Siemens Material Numbers: 10309044 Kit Lots: 43305174, 43278174Catalog Number: 02816634 Siemens Material Numbers:10309045 Kit Lots:43306174, 43279174Expiration Date: July 11, 2015 ARTG number: 175075
  • Manufacturer

Manufacturer