Devices

Device Recall Instrument Manager

  • Model / Serial
    Software alll versions prior to: v7.00.0006 and v8.00. Includes: v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Canada and Britain
  • Product Description
    Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer || Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004
  • Manufacturer
    Data Innovations, Inc.
  • 1 Event

Manufacturer

Data Innovations, Inc.
  • Manufacturer Address
    Data Innovations, Inc., 120 Kimball Ave Ste 100, South Burlington VT 05403-6837
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Instrument Manager
  • Model / Serial
    Device-associated diagnostic software
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
  • Manufacturer
    Roche Molecular Systems, Inc.
Device Recall Instrument Manager software
  • Model / Serial
    S/W Versions 8.05, 8.06, 8.07, 8.08 and 8.09.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) and the country of Canada.
  • Product Description
    Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. || It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
  • Manufacturer
    Data Innovations, Inc.