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Dynex Technologies, Inc. recalls DYNEX Agility, Agility Analyzer, Model No. 67000
Recalled June 8, 2022 · FDA recall Z-1222-2022 · Dynex Technologies
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. · FDA Class II
Units
218 units (17 installed with v1.4.3)
Sold at
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.
Description
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.
Product
DYNEX Agility, Agility Analyzer, Model No. 67000
Manufacturer(s)
Dynex Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →