Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2263-2015Class II

Paragon Laboratory Management

Mckesson Technologies, Inc. / initiated 2014-06-15 / Terminated / root cause: software

McKesson Technologies, Inc. began a recall of Paragon Laboratory Management on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2263-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Mckesson Technologies, Inc.
Product
Paragon Laboratory Management
Product code
JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag
software
FDA root cause
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.
Product codes and lots
Model 12.1 and 12.1.1

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2263-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2263-2015Class IITerminatedVoluntary: Firm initiated