Events

Device Recall Dimension Vista(R) System Vista Drug 4 Calibrator 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
    64596
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1151-2013
  • 사례 시작날짜
    2013-02-21
  • 사례 출판 날짜
    2013-04-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116574
  • 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
    Enzyme immunoassay, digoxin - Product Code KXT
  • 원인
    Siemens has confirmed complaints of low qc and patient recovery with the dimension vista(r) loci(r) digoxin(digxn) flex(r) reagent cartridge when calibrating digxn with either drug 4 cal (kc460) lot 2kd052 or drug 4 cal (kc460a) lot 2kd053. internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/ml.
  • 조치
    The firm initiated their recall of this product by sending an Urgent Medical Device Recall letter dated February 2013 to all Dimension Vista Drug 4 Calibrator customers who received the affected lots. The letter notified them of the issue, the potential risk to health, and actions to be taken by customers.

Device

Device Recall Dimension Vista(R) System Vista Drug 4 Calibrator
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • 제품 설명
    Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
  • 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