Events

Recall of INSTRUMENT MANAGER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DATA INNOVATIONS LLC.

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
    86169
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    When results of "---.-" are received from the sysmex uf-100 instrument and if the user set the driver configuration option "strip zeros from result" to "yes" all versions prior to v7.00.0006 and v8.00.0005 of the sysu100i driver convert the results to "0.00" in instrument manager. the sysmex uf-100 will send "--.-" when the test has a sample error. all five urinalysis tests performed (rbc wbc ec cast and bact) will be resulted as "0.00" in instrument manager. this could lead to misdiagnosis and mistreatment of a patient.

Device

INSTRUMENT MANAGER
  • Model / Serial
    Model Catalog: 8.00.0003 (Lot serial: Not applicable); Model Catalog: 8.00.0002 (Lot serial: Not applicable); Model Catalog: 8.00.0004 (Lot serial: Not applicable); Model Catalog: 7.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0002 (Lot serial: Not applicable); Model Catalog: 7.00.0003 (Lot serial: Not applicable); Model Catalog: 7.00.0005 (Lot serial: Not applicable); Model Catalog: 8.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0004 (Lot serial: Not applicable)
  • Product Description
    Instrument Manager Software using the sysu100i driver that connects to the Sysmex UF-100 instrument
  • Manufacturer
    DATA INNOVATIONS LLC

Manufacturer

DATA INNOVATIONS LLC