FDA Device recall Z-2171-2026
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref by Aniara Diagnostica, citing kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2171-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-01 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Aniara Diagnostica |
| Distribution | US |
Product
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Reason
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Identifiers
| code_info | UDI-DI: 03663537018763; Lot Number: FD1265 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2171-2026%22
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