Device recall
Z-0973-2010: "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on…
FDA device recall · Class II · Kamiya Biomedical Company, LLC
Key facts
| Recall number (Z-number) | Z-0973-2010 |
|---|---|
| Recall event | 53750 |
| Product | "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium… |
| Product code | DCK |
| Recalling firm | Kamiya Biomedical Company, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 21, 2011 |
| 510(k) numbers | K023828 |
| 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