HIGH

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

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Quick Facts at a Glance

Recall Date
April 1, 2026
Hazard Level
HIGH
Brand
Aniara Diagnostica
Geographic Scope
1 states

Hazard Information

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aniara Diagnostica LLC or your healthcare provider for instructions. Notification method: Letter

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Full Description

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 Reason: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control..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. Quantity: 359 units. Distribution: US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI

Safety Guide

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Product Classification

Product Details

Model Numbers
UDI-DI: 03663537018763
Lot Number: FD1265
Affected States
ALL
Report Date
May 20, 2026
Recall Status
ACTIVE