Events

Device Recall Dimension Lipase Flex Reagent Cartridge 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Healthcare Diagnostics, Inc. 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
    79468
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1796-2018
  • 사례 시작날짜
    2017-12-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162393
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
  • 원인
    Calibration failure - confirmed a positive bias with lipl lot fb8109 when compared to other dimension lipl lots. lot fb8109 is not meeting siemens internal specifications for lot-to-lot limits.
  • 조치
    Customers are instructed to: - Discontinue use of Dimension LIPL Assay lot FB8109. ¿- Recalibrate with an alternate lot of Dimension LIPL Assay. ¿- Review their inventory of this lot to determine their laboratory¿fs no-charge replacement needs. ¿- Review the UMDR/UFSN letter with their Medical Director. ¿- Complete and return the Field Correction Effectiveness Check Form attached to the UMDR/UFSN letter within 30 days. - If they have received any complaints of illness or adverse events associated with lot FB8109, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative

Device

Device Recall Dimension Lipase Flex Reagent Cartridge

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, Po Box 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA