Biomerieux, Inc.

2 devices in the database

  • Model / Serial
    Lot numbers: 161402, 161431, 161432, 161477, 161448, 161479, 161507, 161508, 161550, 161551, 161583, 161585, 161595, 161657, 161658. Expanded 3/19/2003 to include lot #161639, 16160 and 1611711. Final expansion of recall initiated 5/30/2003 to include Product Number 252001 (20ml), lot numbers161403, 161480, 161509, 161510, 161552 161586 and 161596.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela
  • Product Description
    Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).
  • Model / Serial
    Product# 252182- Lot #161553, 161580, 161581 and 161661. Additional Catalog number: 252183, Lot number: 161662. Additional lot numbers recalled 3/19 & 31/2003: Lot #161639, 161664, 161716 and 161717. Recall expanded on 5/30/2003 to include the balance of the lot number produced under previous manufacturing practice. Product Number 252182 (6 ml), Lot number 161506; Prduct Number 252183 (20 ml), Lot Number 161503, 161504, 161554, 161582 and 161640.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, FL, GA, IA, IN, MN, NC, NJ, TN, WI. Australia, Brazil, Buenos Aires, Canada, Colombia, Hong Kong, Japan, Korea, Mexico, Netherlands, Thailand and the United Kingdom. There were no government accounts involved.
  • Product Description
    BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704

3 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Address
    Biomerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Source
    USFDA
  • Manufacturer Address
    BIOMERIEUX, INC., 100 Rodolphe St, Durham NC 27712-9402
  • Source
    USFDA