Events

Stratus CS Acute Care Troponin I CalPak 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
    52007
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1555-2009
  • 사례 시작날짜
    2008-04-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-07-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81883
  • 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 MMI
  • 원인
    The firm received and confirmed that some lots of cardiac troponin i (ctnl) calpaks (cctni-cr) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of ctnl testpaks (cctni). this issue may result in failed calibrations due to "slope error" messages or falsely elevated patient sample and quality control (qc) results on calibrations that.
  • 조치
    Siemens Healthcare Diagnostics, Inc. issued an Urgent Field Safety Notice dated April 29, 2008 to all affected customers instructing them to discontinue use of 3 CalPak lots and reduce the shelf-life for the remaining lots. For further information, contact Siemens Healthcare Diagnostics, Inc. at 1-302-631-7672.

Device

Stratus CS Acute Care Troponin I CalPak
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008); and 638105002 (expired August 14, 2008).
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - including United States, United Arab Emirates, Austria, Bermuda, Belize, Canada, Germany, Egypt, India, Japan, Saudi Arabia and Bengal.
  • 제품 설명
    Siemens Stratus CS Acute Care Troponin I CalPak. || In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer.
  • 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