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
v7.00.0001v7.00.0002v7.00.0003v7.00.0004v7.00.0005v8 .00.0001v8.00.0002v8.00.0003and 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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