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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 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 Class II 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 24 systems Z-0571-2014
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