Devices

Device Recall Simplastin Excel S

  • Modelo / 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.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
  • Manufacturer
    Biomerieux, Inc.
  • 1 Event

Fabricante

Biomerieux, Inc.
  • Dirección del fabricante
    Biomerieux, Inc., 100 Rodolphe Street, Durham NC 27712
  • Source
    USFDA