Notice names this product. Aniara Diagnostica’s ZYMUTEST HIA IgG is named in FDA Class II recall Z-2171-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. Identifying details: UDI-DI: 03663537018763; Lot Number: FD1265. Units affected: 359 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Company / brand: Aniara Diagnostica
Affected product: ZYMUTEST HIA IgG
Official ID Z-2171-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.