# FDA recall Z-2345-2025

> **Dynex Technologies, Inc.** · Class II · device recall initiated 2025-07-16.

## Product

Dynex Agility Sample Tips;  Model Number: 67910;  The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.

## Reason for recall

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;

## Key facts

- **Recall number:** Z-2345-2025
- **Recalling firm:** Dynex Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-16
- **Report date:** 2025-08-27

- **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-2345-2025

## Citation

> AI Analytics. FDA recall Z-2345-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2345-2025. Source: US FDA. Licensed CC0.

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