Devices

Device Recall Amplilink

  • Modèle / numéro de série
    Catalog number 03576710190, working substrate SB3-SB
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide to hospitals and laboratories.
  • Description du dispositif
    Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 || COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0
  • Manufacturer
    Roche Molecular Systems, Inc.
  • 1 Event

Fabricant

Roche Molecular Systems, Inc.
  • Adresse du fabricant
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

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Device Recall AMPLILINK
  • Modèle / numéro de série
    Device-associated diagnostic software
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
  • Manufacturer
    Roche Molecular Systems, Inc.
Device Recall Amplilink
  • Modèle / numéro de série
    Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, Working substrate SB3-SB
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide to hospitals and laboratories.
  • Description du dispositif
    Amplilink Software versions 1.1, 1.3, 1.4, 2.41. || COBAS Amplicor CTA & NGA Tests
  • Manufacturer
    Roche Molecular Systems, Inc.
Device Recall AMPLILINK Software, version 3.1.0 to 3.2.2
  • Modèle / numéro de série
    Version 3.1.0, Version 3.1.1, Version 3.1.2, Version 3.2.0, Version 3.2.1, and Version 3.2.2.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. || Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.
  • Manufacturer
    Roche Molecular Systems, Inc.