Instrument Manager driver : Driver sysu100i that connects to the… — Class II medical device recall Z-0571-2014
Terminated recall by Data Innovations, Inc., reported 2014-01-01, distributed nationwide. When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001
| Recall number | Z-0571-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Data Innovations, Inc., South Burlington, VT, United States |
| Recall initiated | 2013-11-06 |
| Classified | 2013-12-24 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2014-12-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 24 systems |
| Reason classes | software |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0571-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.