FDA Device recall Z-3138-2017
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is…
- FDA Device
- Class II
- terminated
- Published 2017-09-27
On 2017-09-27 the FDA classified a Class II recall of K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is… by Kamiya Biomedical, citing the AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3138-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-19 |
| Published | 2017-09-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Kamiya Biomedical |
| Distribution | CA, CT, FL, IA, IL, MA, MD, NC, NJ, NY, OH, TN, TX, VA, WA |
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
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
Identifiers
| code_info | Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3138-2017%22
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