Reported Jan 1, 2014 · Terminated

Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to(…

Data Innovations, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Data Innovations, Inc. · 120 Kimball Ave Ste 100 · South Burlington, VT · 05403-6837

Is this the product you have?

  • Instrument Manager driverDriver 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
Lot codes and dates
  • Software alll versions prior tov7.00.0006 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
Amount recalled
24 systems

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 5, 2014 · Data as of Sep 19, 6:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.