Events

Recall of Device Recall Paragon Laboratory Management

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by McKesson Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71570
  • Event Risk Class
    Class 2
  • Event Number
    Z-2263-2015
  • Event Initiated Date
    2014-06-15
  • Event Date Posted
    2015-07-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138221
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    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.
  • 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.

Device

Device Recall Paragon Laboratory Management
  • Model / Serial
    Model 12.1 and 12.1.1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    Paragon Laboratory Management
  • Manufacturer
    McKesson Technologies, Inc.

Manufacturer

McKesson Technologies, Inc.
  • Manufacturer Address
    McKesson Technologies, Inc., 10735 David Taylor Dr Ste 100, Charlotte NC 28262-1288
  • Source
    USFDA