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 | Terminated |
| Reason | The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct. |
| Product | K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use |
| Quantity | 1398 units |
| Distribution | Worldwide Distribution - US including FL, CA, WA, OH, IA, IL, NJ, NY, NC, MA, TX, CT, MD, VA, Internationally to TN, Czech Republic, Taiwan, Dominican Republic, Switzerland, China, and Jamaica |
| Initiated | 2017-07-19 |
| Classified | 2017-10-20 |
| Terminated | 2018-11-20 |
| Recall number | Z-3138-2017 |
| 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-3138-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77916/
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