Aniara Diagnostica LLC recalls ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Recall date

April 1, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2171-2026

FDA classification

Class II

Brand / firm

Aniara Diagnostica LLC

Sold / distributed

US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI

Why it was recalled

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A