Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ZYMUTEST HIA MonoStrip Recalled by Aniara Diagnostica LLC Due to Residual crystallization of the microplate and recurrent negative...

Date: July 19, 2019
Company: Aniara Diagnostica LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Aniara Diagnostica LLC directly.

Affected Products

ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.

Quantity: 51

Why Was This Recalled?

Residual crystallization of the microplate and recurrent negative controls out of range.

Where Was This Sold?

This product was distributed to 4 states: NH, NY, NC, OH

Affected (4 states)Not affected

About Aniara Diagnostica LLC

Aniara Diagnostica LLC has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report