Warning
Aniara Diagnostica LLC Recalls ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2171-2026Medical Device
Aniara Diagnostica LLC Recalls ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref
Aniara Diagnostica LLC · Class II — Moderate Risk
Product Description
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Aniara Diagnostica LLC initiated the recall on April 1, 2026 affecting 359 units. Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. The product was distributed in CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI. Consumers should check their purchases and discontinue use of any affected product. Contact Aniara Diagnostica LLC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.