Events

Device Recall Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) 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
    59888
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0038-2012
  • 사례 시작날짜
    2011-08-31
  • 사례 출판 날짜
    2011-10-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103938
  • 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
    Immunoassay method, troponin subunit - Product Code JJE
  • 원인
    Internal testing has confirmed that recovery of levels 2 and 3 of locl cardiac troponin i calibrator is lower than expected bottle value. following calibration with locl cardiac troponin i calibrator, lot 1ad045 an upward shift in patient and qc results may be observed.
  • 조치
    Siemens sent an Urgent Field Safety Notice dated August 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard any remaining inventory. Replacement orders would be processed and sent free of charge. Customers were also instructed to complete the attached FIELD CORRECTION EFFECTIVENESS CHECK form and fax it to (302) 631- 8457. Customers were instructed to forward the Safety Notice to anyone to whom they may have distributed the affected product. For any technical questions customers were to contact the Siemens Solutions Center at 800-441-9250.

Device

Device Recall Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621)
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 1AD045
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of GUAM, Austria, Canada, China, Czech Republic, Egypt, France, Germany, Italy, Poland, Portugal, Puerto Rico, Spain and Switzerland.
  • 제품 설명
    Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) || The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module.
  • 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