ZYMUTEST HIA MonoStrip — Class II medical device recall Z-2346-2019
Terminated recall by Aniara Diagnostica LLC, reported 2019-08-28, distributed in NC, NH, NY, OH. Residual crystallization of the microplate and recurrent negative controls out of range.
| Recall number | Z-2346-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aniara Diagnostica LLC, West Chester, OH, United States |
| Recall initiated | 2019-07-19 |
| Classified | 2019-08-22 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2021-06-11 |
| Distributed | NC, NH, NY, OH |
| Countries outside the US | SE |
| Quantity | 51 |
| Model numbers | RK041A |
Product
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Reason for recall
Residual crystallization of the microplate and recurrent negative controls out of range.
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-2346-2019. 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.