CLASS II Device recall · Reported 1 Jan 2014 · FDA Enforcement Report
Instrument Manager driver : Driver sysu100i that connects recalled
Data Innovations is recalling Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer, distributed nationwide in the US. The recall was initiated on 6 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0571-2014
- FDA event ID
- 66754
- Recalling firm
- Data Innovations, South Burlington, VT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Nov 2013
- FDA classified
- 24 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Nov 2013 | Recall initiated by company | |
| 24 Dec 2013 | Classified by FDA | +48 days |
| 1 Jan 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Nationwide Canada and Britain
Questions about this recall
Is Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer recalled?
Yes. Data Innovations recalled Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer on 6 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0571-2014.
Why was it 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
Which lots are affected?
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
Where was it sold?
Nationwide Canada and Britain
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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