# FDA recall Z-1222-2022

> **Dynex Technologies, Inc.** · Class II · device recall initiated 2020-07-05.

## Product

DYNEX Agility, Agility Analyzer, Model No. 67000

## Reason for recall

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, and UK.

## Key facts

- **Recall number:** Z-1222-2022
- **Recalling firm:** Dynex Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-07-05
- **Report date:** 2022-06-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chantilly, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2022

## Citation

> AI Analytics. FDA recall Z-1222-2022. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-1222-2022. Source: US FDA. Licensed CC0.

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