FDA Device recall Z-2347-2019
ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use by Aniara Diagnostica, citing residual crystallization of the microplate and recurrent negative controls out of range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2347-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-19 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Aniara Diagnostica |
| Distribution | NC, NH, NY, OH |
Product
ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
Reason
Residual crystallization of the microplate and recurrent negative controls out of range.
Identifiers
| code_info | F1701571 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2347-2019%22
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