Chantilly, VA, United States
Dynex Technologies, Inc. recalls
2 recalls recorded since 2018, most recently on 16 July 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 July 2025
- Reason
- The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results.
- Distribution
- Domestic: CA, FL, NC, NJ, NY;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2345-2025
- Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Ongoing Class II Medical devices
- Recall started
- 5 July 2020
- 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.
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1222-2022
- DYNEX Agility, Agility Analyzer, Model No. 67000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.