Devices

Device Recall GEM Check Coag Whole Blood Controls

  • Modèle / numéro de série
    Part Number 0620060100 Lot # F9GC2001, Exp. 12/31/2010; and L9GC2002, Exp. 5/31/2011.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
  • Description du dispositif
    GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. || Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125. || Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
  • Manufacturer
    International Technidyne Corporation
  • 1 Event

Fabricant

International Technidyne Corporation
  • Adresse du fabricant
    International Technidyne Corporation, 20 Corporate Pl S, Piscataway NJ 08854-6144
  • Société-mère du fabricant (2017)
    Werfenlife Sa.
  • Source
    USFDA

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Device Recall GEM Check Coag Whole Blood Controls
  • Modèle / numéro de série
    Part Number 06260061600; Lot C9GC5001, Exp. 7/31/2010; G9GC5003, Exp 1/31/2011; J9GC5004, Exp 3/31/2011; and C0GC5001, Exp 10/31/2011.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
  • Description du dispositif
    GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: || IVD. 15/pk. 06260061600. || Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. || Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
  • Manufacturer
    International Technidyne Corporation