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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