Recall- Control samples aspirated from wrong SmartKit

Company: Dynex Technologies, Inc.
Date of Enforcement Report: 7/5/2020
Class II


DYNEX Agility, Agility Analyzer, Model No. 67000

Recall Number:



Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay’s SmartKit will be used instead of the correct control, which may lead to delayed patient results.


Dynex Technologies, Inc. on 7/5/2020. Voluntary: Firm initiated


218 units (17 installed with v1.4.3)


Worldwide distribution – US Nationwide distribution in the states of AL, CA, DC, FL, GA, IL, IN, MA, MD, MI, NE, NJ, NY, OH, PA, PR, TN, TX, UT, VA, WI, WV and the countries of Belgium, Brazil, China, Czech Republic, France, Germany, Mexico, Qatar, Romania, Russia, South Korea, Switzerland, Taiwan, and UK

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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