Medical device recalls Moderate risk

Kamiya Biomedical Company, LLC recalls K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

Recall date
September 28, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0271-2023
FDA classification
Class II
Brand / firm
Kamiya Biomedical Company, LLC
Sold / distributed
Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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