Events

Dimension Vista(R) Cuvettes 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
    59746
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0031-2012
  • 사례 시작날짜
    2011-08-08
  • 사례 출판 날짜
    2011-10-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103543
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical - Product Code JJE
  • 원인
    Siemens healthcare diagnostics has confirmed a low frequency defect in the molding of the cuvettes that may result in cuvette ring and cuvette loader jams. it has been determined that the issue is related to a molding defect with the cuvette flange or "wing" breaking, resulting in an error condition. therefore, patient results are not impacted.
  • 조치
    Siemens Healthcare Diagnostics sent a Urgent Field Safety Notice letter dated August 2011, to all affected customers. The letter identifed the product the problem and the action needed to be taken by customer. Customers were instructed to discard all cuvette cartridges of the identified lots. Customers were also informed that until a replacement lot is available, if an error is encountered, they may contact the Technical Solutions Center for assistance at (800) 441-9245. For replacement product , please call the Siemens Atlanta Customer Service Center at (800) 241-0420.

Device

Dimension Vista(R) Cuvettes
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number KS850 - lots: X05-076-11, X05-081-11, X05-086-11, X05-090-11, X05-091-11, X05-096-11, X05-101-11, X05-108-11, X05-117-11, X05-122-11, X05-125-11, and X05-126-11.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and Puerto Rico., and the countries of Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Spain, Switzerland, Australia, Japan, South Korea, and Canada.
  • 제품 설명
    Dimension Vista(R) Cuvettes || The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA