Aniara Diagnostica LLC recalls ZYMUTEST HIA IgG
- Recalling company
- Aniara Diagnostica LLC
- Product
- ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
- Reason
- Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 1, 2026
- Reported
- May 20, 2026
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
- Status
- Ongoing
- Quantity
- 359 units
- Lot / codes
- UDI-DI: 03663537018763; Lot Number: FD1265
- Company location
- West Chester, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2171-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2171-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.