Device recall
Z-2641-2010: PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers…
FDA device recall · Class II · Polymer Technology Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2641-2010 |
|---|---|
| Recall event | 56188 |
| Product | PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268. |
| Product code | NBW |
| Recalling firm | Polymer Technology Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2011 |
| 510(k) numbers | K071507 |
| FEI number | 3015525148 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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