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U.S. Department of Health and Human Services

Class 2 Device Recall Paragon Laboratory Management

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  Class 2 Device Recall Paragon Laboratory Management see related information
Date Initiated by Firm June 15, 2014
Date Posted July 27, 2015
Recall Status1 Terminated 3 on February 01, 2022
Recall Number Z-2263-2015
Recall Event ID 71570
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Paragon Laboratory Management
Code Information Model 12.1 and 12.1.1
Recalling Firm/
Manufacturer		 McKesson Technologies, Inc.
10735 David Taylor Dr Ste 100
Charlotte NC 28262-1288
For Additional Information Contact Paul Sumner
404-338-3556
Manufacturer Reason
for Recall		 For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 2012, the Final Cumulative Report may incorrectly display the data.
FDA Determined
Cause 2		 Software design
Action McKesson issued a Clinical Alert to notify customers of the issue on June 15, 2015, and requested that customers disable Cumulative Reporting. McKesson is identifying customers currently in a live environment with Microsoft SQL Server 2012 and the affected configuration. McKesson will provide those customers with corrective software, and provide assistance in generating correct reports and updating those to the patient folder. For further questions, please call (404) 338-3556.
Quantity in Commerce 128
Distribution Nationwide Distribution including Puerto Rico and to the states of : CA, CO., CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK, OA, PA, SC, SD, TN, TX, VT, VA, WV and WY.
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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