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

PRODUCT

DYNEX Agility, Agility Analyzer, Model No. 67000

Recall Number:

Z-1222-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

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

VOLUME OF PRODUCT IN COMMERCE

218 units (17 installed with v1.4.3)

DISTRIBUTION

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