DYNEX Agility — Class II medical device recall Z-1222-2022
Ongoing recall by Dynex Technologies, Inc., reported 2022-06-08, distributed nationwide. Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolv
| Recall number | Z-1222-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dynex Technologies, Inc., Chantilly, VA, United States |
| Recall initiated | 2020-07-05 |
| Classified | 2022-06-02 |
| Reported by FDA | 2022-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CH, CN, CZ, DE, FR, GB, KR, MX, QA, RO, RU, TW |
| Reason classes | potency, software |
| UPC / GTIN / UDI-DI | 05060456180058 |
| Serial numbers | 1GXA0021, 1GXA0022, 1GXA0023, 1GXA0024, 1GXA0025, 1GXA0026, 1GXA0027, 1GXA0028, 1GXA0029, 1GXA0030, 1GXA0031, 1GXA0032, 1GXA0033, 1GXA0034, 1GXA0035, 1GXA0036, 1GXA0037, 1GXA0038, 1GXA0039, 1GXA0040, 1GXA0041, 1GXA0042, 1GXA0043, 1GXA0044, 1GXA0045 and 193 more |
| Model numbers | 67000 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1222-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.