Device recall
Z-3138-2017: K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY…
FDA device recall · Class II · Kamiya Biomedical Company, LLC
Key facts
| Recall number (Z-number) | Z-3138-2017 |
|---|---|
| Recall event | 77916 |
| 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… |
| Product code | JIX |
| Recalling firm | Kamiya Biomedical Company, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2018 |
| 510(k) numbers | K993853 |
| FEI number | 2084025 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database