Data Innovations Instrument Manager Driver Software Recall for Sysmex UF-100
Data Innovations is recalling Instrument Manager driver software for the Sysmex UF-100 analyzer due to potential sample errors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential sample errors without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Data Innovations, Inc. is recalling the Instrument Manager driver software (sysu100i) used to connect to the Sysmex UF-100 analyzer. The recall affects specific software versions prior to v7.00.0006 and v8.00.0005, including versions 7.00.0001 through 7.00.0005 and 8.00.0001 through 8.00.0004.
The recall was initiated because the software, when configured with the "Strip Zeros from Result" option set to "Yes," may result in sample errors. This issue could affect the accuracy of data processing for the connected analyzer.
Approximately 24 systems were distributed nationwide, as well as in Canada and Britain. Users of the affected software versions should contact Data Innovations, Inc. for further instructions on how to resolve the issue.
The recalled product
- 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
- Manufacturer
- Data Innovations, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateSysmex UF-1000i Urine Analyzer Recalled for Software Date Calculation Error
FDA (Devices) · 2014-02-19
- HighData Innovations Recalls ProVue Instrument Driver for JResultNet Software
FDA (Devices) · 2014-09-24
- ModerateRoche DataInnovations Instrument Manager Software Recalled for Diagnostic Issue
FDA (Devices) · 2012-12-19
- HighSiemens syngo Lab Data Manager Software Recall for Configuration Errors
FDA (Devices) · 2014-07-09
- HighData Innovations Recalls JResultNet Software Due to Patient Data Mismatch Risk
FDA (Devices) · 2017-04-05
- HighImmunoassay Analyzer Software Error May Cause Sample Result Mix-up
FDA (Devices) · 2023-10-18