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

Medical DevicesSource: FDA (device) · Date: 2026-05-20

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Aniara Diagnostica LLC
Product
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Reason / 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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Recall initiated
2026-04-01
Code info
UDI-DI: 03663537018763; Lot Number: FD1265
Product quantity
359 units
Voluntary mandated
Voluntary: Firm initiated
City
West Chester
State
OH
Country
United States
Event id
98754
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