Class II — Kamiya Biomedical Company, LLC
| Recalling firm | KAMIYA BIOMEDICAL COMPANY LLC |
|---|---|
| Registered facility | KAMIYA BIOMEDICAL COMPANY LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | IgA Reagent may start showing cloudiness over time, which can affect assay performance. |
| Product | K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 |
| Quantity | 165 |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic. |
| Initiated | 2022-09-28 |
| Classified | 2022-11-21 |
| Recall number | Z-0271-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Kamiya Biomedical Company, LLC (Z-0271-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91030/
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