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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 April 17, 2008
Date Posted October 31, 2008
Recall Status1 Terminated 3 on December 05, 2011
Recall Number Z-0207-2009
Recall Event ID 48174
Product Classification Calculator/data processing module - Product Code JQP
Product Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3.

Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection management, specimen tracking, and use with microbiology and molecular diagnostics. Key capabilities include:

1) Autoverify results directly from analyzers and reference laboratories
2) Track tubes and containers from order to final disposition
3) Monitor key metrics such as turnaround time and utilization using management reports
4) Produce pathology results with Structured Reports
5) Suggest microbiology workups online according to defined SOPs and rules
6) All data entered into the system is accessible through audit trails and Ad Hoc Report tools
7) Any change to patient results (inquiry, reports) is logged and available for review
Code Information Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3.
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 has identified a problem with IGO interfaces when performing an Online File Cleanup (OFC) that can lead to the test results of one patient filing to another patient when the order codes are the same. Performing an OFC prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong pat
FDA Determined
Cause 2		 Component design/selection
Action Customers were sent a preliminary notice on 4/17/2008 followed by customer notice PSN-08-04 on 05/07/2008 via email. The notice advises that this notice is follow-up to the Preliminary notice distributed on 4/17/08 and applies to all clients who have an Instrument Generated Order (IGO) interface. Sunquest has identified a problem with IGO interfaces when performing an Online File Cleanup (OFC) that can lead to the test results of one patient filing to another patient when the order codes are the same. Performing an OFC prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong patient. When this occurs, Sunquest generated reports and inquiry contains the incorrect results. The letter provides the various steps that cause the issue to occur. Sites Potentially Affected by this Problem: Sunquest Laboratory using Instrument Generated Orders (IGO) Interface, Version 5.3 and later Action Sunquest Information Systems is taking to eliminate this Problem: Change Request 1-62VWLJ has been created to address this issue. This will be available as part of Sunquest Laboratory Instrument Build version 1.6.0023 and later. To request the software correction, customers can create a Service request via the Client support Webpage at www.sunquestinfo.com/supportweb. The notice also provides temporary procedural instructions: Effective immediately, do NOT perform Online File Cleanup (OFC) on any IGO instrument interface methods. -Manual OFC should not be performed using functions OFC, or Instrument Maintenance (IX or IXM), option 11 for IGO interfaces only. -If using function Instrument Maintenance (IX or IXM), option 1, 2, 2, Method, 2 (Automatic File Cleanup). This should be set to "N". Then stop and re-start the Instrument Results Processor. Note: Online file cleanup for non-IGO interfaces needs to be performed as usual. -Pending and Overdue Logs need to be monit
Quantity in Commerce 419 clients had the affected code
Distribution Worldwide Distribution --- including USA and countries of Canada, Bermuda, Ireland, United Kingdom, United Arab Emirates, and Saudi Arabia.
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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