Class II — Potential Health Hazard

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

K-ASSAY IgA Immunoturbidimetric Assay Recalled by Kamiya Biomedical Company, LLC Due to IgA Reagent may start showing cloudiness over time,...

Date: September 28, 2022
Company: Kamiya Biomedical Company, LLC
Status: Ongoing
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 Kamiya Biomedical Company, LLC directly.

Affected Products

K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

Quantity: 165

Why Was This Recalled?

IgA Reagent may start showing cloudiness over time, which can affect assay performance.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Kamiya Biomedical Company, LLC

Kamiya Biomedical Company, LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

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