Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Instrument Manager driver : Driver sysu100i that connects to the Recalled by Data Innovations, Inc. Due to When connected to the Sysmex UF-100, the Instrument...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Data Innovations, Inc. directly.
Affected Products
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
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Data Innovations, Inc.
Data Innovations, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report