Class II — Data Innovations, Inc.
| Recalling firm | DATA INNOVATIONS LLC |
|---|---|
| Registered facility | DATA INNOVATIONS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| Product | 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 |
| Quantity | 24 systems |
| Distribution | Nationwide Canada and Britain |
| Initiated | 2013-11-06 |
| Classified | 2013-12-24 |
| Terminated | 2014-12-05 |
| Recall number | Z-0571-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Data Innovations, Inc. (Z-0571-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66754/
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