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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description 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
Recall Number Z-0571-2014
Classification Class II
Code Info 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
Product Distributed Qty 24 systems
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

Event Detail

Event Id 66754
Product Type Devices
Status Ongoing
Recalling Firm Data Innovations, Inc.
City South Burlington
State VT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-06
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide Canada and Britain
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