Device Recall SigmaAldrich Histopaque1119

  • Model / Serial
    Lots 038K6030, 126K6002, and 079K6047.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sigma-Aldrich Mfg LLC, 545 S Ewing Ave, Saint Louis MO 63103-2932
  • Manufacturer Parent Company (2017)
  • Source
    USFDA