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U.S. Department of Health and Human Services

Class 2 Device Recall Instrument Manager

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  Class 2 Device Recall Instrument Manager see related information
Date Initiated by Firm November 06, 2013
Date Posted December 24, 2013
Recall Status1 Terminated 3 on December 05, 2014
Recall Number Z-0571-2014
Recall Event ID 66754
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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
Code Information 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
Recalling Firm/
Manufacturer		 Data Innovations, Inc.
120 Kimball Ave Ste 100
South Burlington VT 05403-6837
For Additional Information Contact SAME
802-658-2850 Ext. 414
Manufacturer 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
FDA Determined
Cause 2		 Software design
Action Data Innovation notified consignees by Important Medical Device Recall Notification dated 11/5/13 to all list serv recipients of the problem and posted critical alert on Customer Web Portal. A certified letter was issued to impacted customers and consignees if no response was recieved from e-mail.
Quantity in Commerce 24 systems
Distribution Nationwide Canada and Britain
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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