Official recall notice
FDA DeviceClass IINotable
ZYMUTEST HIA IgG Recall (May 2026) – Aniara Diagnostica
Product: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
- Recall date
- 2026-05-20
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Product description
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.