Dade Behring , Inc.

6 dispositifs dans la base de données

  • Modèle / numéro de série
    Lot numbers 544531 to 544548 and 544502 to 544504.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped nationwide to medical facilities.
  • Description du dispositif
    Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
  • Modèle / numéro de série
    Software version 3.5
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.
  • Description du dispositif
    StreamLab Analytical Workcell. General Purpose Laboratory Device.
  • Modèle / numéro de série
    Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
  • Description du dispositif
    DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
  • Modèle / numéro de série
    Lot 540624, Lot 540625, and Lot 540626
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.
  • Description du dispositif
    BC Thrombin Reagent . Thrombin Time Test
  • Modèle / numéro de série
    Lots 541428, 541429, expiration date of Nov 2006
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The heparin reagent, which is a component of a test kit, wasdistributed to direct accounts in the following states: AZ, CA, CO, FL, IA, IL, IN, KY, OH, MA, MD, MI, MN, NC, NE, NJ, NM, NY, PA,TN, TX, WI, WV. Further, there are foreign countries also affected in this recall action, as listed: Australia, Canada, France, Finland, Germany, Israel, Italy, Spain, United kingdom, Spain
  • Description du dispositif
    Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
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  • Adresse du fabricant
    Dade Behring , Inc., 500 GBC Dr., Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Source
    USFDA