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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2263-2015 | Class II | Terminated | Voluntary: Firm initiated |
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