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U.S. Department of Health and Human Services

Class 2 Device Recall Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface

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  Class 2 Device Recall Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface see related information
Date Initiated by Firm November 19, 2009
Date Posted November 06, 2012
Recall Status1 Terminated 3 on November 06, 2012
Recall Number Z-0251-2013
Recall Event ID 63380
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Code Information v3.0.0_07222004 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		 The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Sunquest sent an "URGENT-PRODUCT SAFETY NOTICE: PSN-09-06" letter dated November 19, 2009 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were informed that Sunquest Application Interfacing would be contacting their facility for scheduling to correct the issue.
Quantity in Commerce 9 units
Distribution Nationwide Distribution.
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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