CLASS II ONGOING Device recall · Reported 27 Aug 2025 · FDA Enforcement Report
Dynex Agility Sample Tips recalled by Dynex Technologies
Dynex Technologies is recalling Dynex Agility Sample Tips, distributed in California, Florida, North Carolina, New Jersey, New York. The recall was initiated on 16 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2345-2025
- FDA event ID
- 97319
- Recalling firm
- Dynex Technologies, Chantilly, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jul 2025
- FDA classified
- 21 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 16 Jul 2025 | Recall initiated by company | |
| 21 Aug 2025 | Classified by FDA | +36 days |
| 27 Aug 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Where it was distributed
Domestic: CA, FL, NC, NJ, NY;
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;
Where was it sold?
Domestic: CA, FL, NC, NJ, NY;
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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