Dade Behring , Inc.

6 devices in the database

  • Model / Serial
    Lot numbers 523785, 523785A, 523785B, and 523787
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to one diagnostic facility in PA. The products were also shipped to Germany, Poland, Spain, France, Italy, Portugal, Mexico, Thailand, and Uruguay.
  • Product Description
    Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
  • Model / Serial
    Lots 541428, 541429, expiration date of Nov 2006
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
  • Model / Serial
    Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
  • Product Description
    DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
  • Model / Serial
    Lot 540624, Lot 540625, and Lot 540626
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    BC Thrombin Reagent . Thrombin Time Test
  • Model / Serial
    Software version 3.5
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    StreamLab Analytical Workcell. General Purpose Laboratory Device.
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One manufacturer with a similar name

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  • Manufacturer Address
    Dade Behring , Inc., 500 GBC Dr., Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Source
    USFDA