FDA-Device2022-06-08Class II
DYNEX Agility, Agility Analyzer, Model No. 67000
Dynex Technologies, Inc.
Hazard
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.
Sold states
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.
Affected count
218 units (17 installed with v1.4.3)
Manufactured in
14340 Sullyfield Cir, N/A, Chantilly, VA, United States
Products
DYNEX Agility, Agility Analyzer, Model No. 67000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2022Don't want to check this manually?
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