Device recall
Z-0975-2010: PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A…
FDA device recall · Class III · Polymer Technology Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0975-2010 |
|---|---|
| Recall event | 53761 |
| Product | PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood. |
| Product code | CHH |
| Recalling firm | Polymer Technology Systems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 20, 2010 |
| 510(k) numbers | K071593 |
| 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