Device recall
Z-1614-2013: VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number…
FDA device recall · Class III · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-1614-2013 |
|---|---|
| Recall event | 65247 |
| Product | VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600… |
| Product code | CEM |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 12, 2015 |
| 510(k) numbers | K083680 |
| FEI number | 1000136573 |
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