Events

Device Recall Dimension QuikLYTE Dilution Check 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
    70627
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1398-2015
  • 사례 시작날짜
    2015-02-24
  • 사례 출판 날짜
    2015-04-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134171
  • 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
    Electrode, ion specific, potassium - Product Code CEM
  • 원인
    A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. the dilution check correction would be detected by qc; however, if not detected by qc, the calibration curve would be decreased and cause elevated sodium, potassium and chloride patient results.
  • 조치
    An Urgent Medical Device Recall letter, dated February 2015, was provided to all Dimension¿ system customers who received the affected lot to notify them that Siemens confirmed customer complaints of failing dilution checks when using QuikLYTE Dilution Check lot 4MD707. The letter also instructed them to immediately discontinue use and discard all inventory of Dimension QuikLYTE¿ Dilution Check lot 4MD707. Siemens offered a no charge replacement with a non-impacted lot.

Device

Device Recall Dimension QuikLYTE Dilution Check
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number S640, Siemens Material Number (SMN) 10444872, Lot Number 4MD707
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. || Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended for the quantitative measurement of sodium, potassium, chloride and total carbon dioxide in human serum and heparinized plasma. They are also intended for the quantitative measurement of Na+, K+ and Cl- in urine.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

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