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U.S. Department of Health and Human Services

Class 3 Device Recall Sunquest Laboratory

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 Class 3 Device Recall Sunquest Laboratorysee related information
Date Initiated by FirmNovember 15, 2011
Date PostedOctober 17, 2012
Recall Status1 Terminated 3 on October 19, 2012
Recall NumberZ-0073-2013
Recall Event ID 62516
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductSunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Code Information Versions 6.4.0 and later
FEI Number 1000306472
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		Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
FDA Determined
Cause 2		Software design
ActionUrgent - Product Safety Notice: PSN-11-06,dated, 15 November 2011, was sent to customers. Costumers should follow instructions in the notification letter. To request the software correction, create a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb. Return receipt acknowledging PSN-11-06 is required . Client Support can be reached at 1-877-239-6337 for U.S. and Canadian sites and at +44 (0) 161 335 0562 for International sites.
Quantity in Commerce127 sites
DistributionNationwide distribution
Total Product Life CycleTPLC 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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