Company: Dynex Technologies, Inc.
Date of Enforcement Report: 7/5/2020
DYNEX Agility, Agility Analyzer, Model No. 67000
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
VOLUME OF PRODUCT IN COMMERCE
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