Events

Device Recall Dimension Vista Myoglobin 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
    69937
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0946-2015
  • 사례 시작날짜
    2014-11-24
  • 사례 출판 날짜
    2015-01-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132004
  • 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
    Calibrator, secondary - Product Code JIT
  • 원인
    Dimension vista myoglobin calibrator (myo cal) may produce a positive shift in myo qc and patient test results that exceeds acceptance criteria for this product. a positive shift observed up to 12% at myo concentrations within and above the reference range of the assay. depending on quality control limits, this drift may not be detected.
  • 조치
    The firm, Siemens, sent an "Urgent Medical Device Recall"letter dated November 2014, to all customers who received the affected lot. The letter described the product, problem and actions to be taken. The customers were instructed to: Review this letter with your Medical Director; discard your remaining inventory; recalibrate with an alternate in-date lot of MYO CAL, and complete and return the attached Field Correction Effectiveness Check Form and fax the form to (312) 275-7795. Siemens will replace any unused inventory of the affected lot at no charge. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at 800-441-9250 or your local Siemens technical support representative.

Device

Device Recall Dimension Vista Myoglobin Calibrator
  • 모델명 / 제조번호(시리얼번호)
    Lot 4FD085, exp. 12-01-2014
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • 제품 설명
    Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 || Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
  • 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