← FDA ENFORCEMENT
Z-2171-2026Class II

Aniara Diagnostica LLC

Recalling firm
Aniara Diagnostica LLC
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Firm state
OH
Product quantity
359 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Product description

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Code / lot info

UDI-DI: 03663537018763; Lot Number: FD1265

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.