Events

SigmaAldrich Histopaque1077 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
    53560
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0974-2010
  • 사례 시작날짜
    2009-09-04
  • 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=85861
  • 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
    Lymphocyte separation medium - Product Code JCF
  • 원인
    Some of the product was contaminated with pseudomonas mendocina.
  • 조치
    An "IMPORTANT PRODUCT NOTIFICATION" dated September 4, 2009 was sent to customers via regular mail. The notification letter described product, problem and action to be taken. The customers were requested to immediately discontinue use of the product and discard all remaining material. Subrecall was requested if the product was further distributed. The customer is to complete and fax the notification form to (314) 286-7829 to assure proper replacement for material they have not used and which is to be discarded. Should you have any questions, please contact Signma-Aldrich Technical Service at (800) 325-5832.

Device

SigmaAldrich Histopaque1077
  • 모델명 / 제조번호(시리얼번호)
    Lot #038K6170, Exp. 2011-04
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and Great Britain, France, China, Germany, Australia, Canada, Mexico, Korea, Singapore, India, Japan, Colombia, Hong Kong, Peru, Taiwan, and Venezuela.
  • 제품 설명
    Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. || This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null" lymphocytes.
  • 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