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U.S. Department of Health and Human Services

Class 3 Device Recall Sunquest Laboratory SMART and SMART Select

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  Class 3 Device Recall Sunquest Laboratory SMART and SMART Select see related information
Date Initiated by Firm August 12, 2011
Date Posted August 21, 2012
Recall Status1 Terminated 3 on September 04, 2012
Recall Number Z-2229-2012
Recall Event ID 62452
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Product Usage: for clinical use
Code Information Version 6.4.2
Recalling Firm/
Manufacturer		 Sunquest Information Systems, Inc.
250 S Williams Blvd
Tucson AZ 85711-4472
For Additional Information Contact
520-570-2252
Manufacturer Reason
for Recall		 In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
FDA Determined
Cause 2		 Process design
Action Sunquest sent an Urgent - Product Safety Notice letter dated August 12, 2011 to all affected customers. The letter identified the affected product, summary of the problem, actions to eliminate the problem and actions to be taken by clients. Sunquest will distribute a new maintenance release. Client Support can be reached at 1-877-239-0337 for U.S and Canadian sites and at +44 (0) 101-335-0562 for international sites.
Quantity in Commerce 47 sites
Distribution US Nationwide Distribution
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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