ZYMUTEST HIA IgG — Class II medical device recall Z-2171-2026
Ongoing recall by Aniara Diagnostica LLC, reported 2026-05-20, distributed nationwide. Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 Octo
| Recall number | Z-2171-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aniara Diagnostica LLC, West Chester, OH, United States |
| Recall initiated | 2026-04-01 |
| Classified | 2026-05-12 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 359 units |
| UPC / GTIN / UDI-DI | 03663537018763 |
| Lot numbers | FD1265 |
| Model numbers | RK040A |
Product
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Reason for recall
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
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-2171-2026. 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.