Events

Device Recall Dade Actin Activated Cephaloplastin Reagent 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
    71273
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1703-2015
  • 사례 시작날짜
    2015-03-25
  • 사례 출판 날짜
    2015-06-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137183
  • 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
    Activated partial thromboplastin - Product Code GFO
  • 원인
    Recovery for assayed controls are out of assigned ranges. a drift >3 seconds in the normal aptt range and/or >15% in the pathological range has been observed. patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range.
  • 조치
    On March 24, 2015 an Urgent Medical Device Recall letter was mailed to all affected customers to notify them about the issue, associated risks, and actions to be taken.

Device

Device Recall Dade Actin Activated Cephaloplastin Reagent
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number B4218-1, Material Number 10445709, lot numbers 557128, 557129, 557130, 557131, 557132, 557133, 557134, 557135, 557140, 557141 , expiration dates:10/31/2015, 11/21/2015, 2/16/2016
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. US naionwide including Puerto Rico, Barbados and Mexico.
  • 제품 설명
    Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.
  • 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