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U.S. Department of Health and Human Services

Class 2 Device Recall Sunquest Laboratory

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  Class 2 Device Recall Sunquest Laboratory see related information
Date Initiated by Firm November 03, 2011
Date Posted November 06, 2012
Recall Status1 Terminated 3 on November 06, 2012
Recall Number Z-0250-2013
Recall Event ID 63369
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Sunquest Laboratory, version 7.0

not available
Code Information not available
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		 Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.
FDA Determined
Cause 2		 Software design
Action Sunquest Information Systems, Inc. sent a recall letter dated November 3, 2011, to all affected customers. Customers were informed of the problem identified and the actions to be taken. Customers were informed that a change request CR11-00174907 has been created to address this issue. This will be available as part of Sunquest Laboratory version 7.0.1. To request the software correction, customers were instructed to create a Case via the Client Support webpage at www.sunquestinfo.com/supportweb. Then choose a new case, and finally select work queue and select software request. Customers with questions were instructed to call (877) 239-6337 for US and Canadian sites and at +44 (0) 161 335 0562 for international sites. For questions regarding this recall call 520-570-2252.
Quantity in Commerce 14 sites
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Ireland
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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