Class II

Medical Device Recall: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Aniara Diagnostica LLC · April 1, 2026

Reason for Recall

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

359 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2171-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.