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

Recalled May 20, 2026 · FDA recall Z-2171-2026 · Aniara Diagnostica

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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.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

Units

359 units

Sold at

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

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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Product

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

Manufacturer(s)

Aniara Diagnostica LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →