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
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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
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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 |
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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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