Class II — Dynex Technologies, Inc.
| Recalling firm | Dynex Technologies, Inc. |
|---|---|
| Registered facility | DYNEX TECHNOLOGIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | DYNEX Agility, Agility Analyzer, Model No. 67000 |
| Quantity | 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. |
| Initiated | 2020-07-05 |
| Classified | 2022-06-02 |
| Recall number | Z-1222-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Dynex Technologies, Inc. (Z-1222-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90099/
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