The Recall Desk
ModerateFDA (Devices)·Z-2263-2015·Announced 2015-08-05

McKesson Paragon Laboratory Management Software Recall for Data Display Errors

McKesson Technologies is recalling Paragon Laboratory Management software versions 12.1 and 12.1.1 because the Final Cumulative Report may display incorrect data when used with Microsoft SQL Server 2012.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect data display in a report, which is a functional defect rather than a direct physical safety risk like injury or death, fitting the criteria for moderate severity involving low-risk issues or voluntary precautionary measures.

Plain-English summary

McKesson Technologies, Inc. is recalling 128 units of Paragon Laboratory Management software, specifically versions 12.1 and 12.1.1. The recall is due to a software defect where the Final Cumulative Report may incorrectly display data if the system is used with Microsoft SQL Server 2012.

The affected software was distributed nationwide, including Puerto Rico and to numerous states across the United States. The source text does not specify any reported illnesses, injuries, or deaths associated with this recall.

Users of the affected software should contact McKesson Technologies for further instructions on how to resolve the data display issue. The recall is classified as Class II by the FDA.

The recalled product

Product
Paragon Laboratory Management
Affected units
128

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model 12.1 and 12.1.1

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Same manufacturer · McKesson Technologies, Inc.

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