Device recall
Z-1903-2012: PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are…
FDA device recall · Class II · Polymer Technology Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1903-2012 |
|---|---|
| Recall event | 61966 |
| Product | PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use… |
| Product code | JFY |
| Recalling firm | Polymer Technology Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 20, 2012 |
| 510(k) numbers | K010456 |
| FEI number | 3015525148 |
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