Events

Recall of Device Recall Instrument Manager

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Data Innovations, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66754
  • Event Risk Class
    Class 2
  • Event Number
    Z-0571-2014
  • Event Initiated Date
    2013-11-06
  • Event Date Posted
    2013-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123276
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    When connected to the sysmex uf-100, the instrument manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005, 8.00.0001, 8.00.0002, 8.00.0003, and 8.00.0004, and is configured with option "strip zeros from result" set to "yes" may result in sample error.
  • Action
    Data Innovation notified consignees by Important Medical Device Recall Notification dated 11/5/13 to all list serv recipients of the problem and posted critical alert on Customer Web Portal. A certified letter was issued to impacted customers and consignees if no response was recieved from e-mail.

Device

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.

Manufacturer

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