K-Assay — Class II medical device recall Z-3138-2017
Terminated recall by Kamiya Biomedical Company, LLC, reported 2017-09-27, distributed in CA, CT, FL, IA, IL, MA, MD, NC…. The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot
| Recall number | Z-3138-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kamiya Biomedical Company, LLC, Tukwila, WA, United States |
| Recall initiated | 2017-07-19 |
| Classified | 2017-10-20 |
| Reported by FDA | 2017-09-27 |
| Terminated | 2018-11-20 |
| Distributed | CA, CT, FL, IA, IL, MA, MD, NC, NJ, NY, OH, TN, TX, VA, WA |
| Countries outside the US | CH, CN, CZ, DO, JM, TW |
| Quantity | 1,398 units |
| Lot numbers | D647, D755, F648, F649, G650, J651, L652, N653, N654 |
| Model numbers | KAI--016C |
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
Reason for recall
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3138-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.