ClearanceBrief
Recall Z-2263-2015 ยท JQP Calculator/Data Processing Module, For Clinical Use

McKesson Technologies, Inc.

Paragon Laboratory Management

DateJul 27, 2015 (initiated Jun 15, 2014)
StatusTerminated
ReasonFor 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.
Root causeSoftware design
ActionMcKesson 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.
Quantity128
DistributionNationwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.