FDAFDA · Food and drugs·Recall number Z-2171-2026
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Published May 20, 2026 · Recall initiated: April 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aniara Diagnostica LLC
- Distributor
- US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
- Lot
- UDI-DI: 03663537018763; Lot Number: FD1265
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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