FDAHealthApril 1, 2026

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

⚠️ Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 1, 2026

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

What's affected?

Product: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Brand: Aniara Diagnostica LLC
Lot code: FD1265

Additional details

UDI-DI: 03663537018763; Lot Number: FD1265

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 359 units.

View original FDA notice →

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