Events

Device Recall SigmaAldrich Histopaque1119 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sigma-Aldrich Mfg LLC 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
    53956
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0977-2010
  • 사례 시작날짜
    2009-12-08
  • 사례 출판 날짜
    2010-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86942
  • 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
    Histopaque-1119 - Product Code JCF
  • 원인
    Instructions for use (ifu) was revised to recommend sterile filtering of the product under certain circumstances.
  • 조치
    The recalling firm issued an "Urgent Field Correction" notice dated December 7, 2009 via regular mail on December 8, 2009 which explains the reason for the field correction and instructs the user to review the enclosed, revised Instructions for Use (IFU) prior to further use of the product. The customer is requested to complete the acknowledgement information and return it to the recalling firm via FAX or e-mail. Direct questions to Sigma-Aldrich by calling 1-800-505-6275, extension 1232.

Device

Device Recall SigmaAldrich Histopaque1119
  • 모델명 / 제조번호(시리얼번호)
    Lots 038K6030, 126K6002, and 079K6047.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Canada, Mexico, United Arab Emirate, Australia, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Ecuador, France, Great Britain, Hong Kong, Israel, India, Italy, Jamaica, Japan, Korea, Panama, Peru, Paraguay, Saudi Arabia, Singapore, Thailand, West Indies, Taiwan, Venezuela, and South Africa.
  • 제품 설명
    Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. || The product is for use in separating mononuclear cells and granulocytes when used with Histopaque-1077.
  • Manufacturer
    Sigma-Aldrich Mfg LLC

Manufacturer

Sigma-Aldrich Mfg LLC
  • 제조사 주소
    Sigma-Aldrich Mfg LLC, 545 S Ewing Ave, Saint Louis MO 63103-2932
  • 제조사 모회사 (2017)
    Merck KGaA
  • Source
    USFDA