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U.S. Department of Health and Human Services

Class 3 Device Recall Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

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 Class 3 Device Recall Sunquest Laboratory SMART & Sunquest Laboratory SMART Selectsee related information
Date Initiated by FirmApril 28, 2011
Date PostedAugust 16, 2012
Recall Status1 Terminated 3 on September 04, 2012
Recall NumberZ-2216-2012
Recall Event ID 62344
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductSunquest Laboratory SMART & Sunquest Laboratory SMART Select
Code Information Version 6.3.0 and Later
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 Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or
FDA Determined
Cause 2		Software design
ActionSunquest sent an Urgent Product Safety Notice dated April 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For the 103 sites that still have this issue Sunquest distribute a new maintenance release. Customers were instructed to use LabAccess Results Workstation (LARS) instead of Online Entry when entering results for instrument method codes that are defined to use replicate tests that are typically ordered on the same accession. Customers were also instructed to share this notification with appropriate laboratory personnel. Customers were questions should call 520-570-2000. For questions regarding this recall call 520-570-2252.
Quantity in Commerce103 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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