Device recall
Z-0833-2020: PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer…
FDA device recall · Class II · Polymer Technology Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0833-2020 |
|---|---|
| Recall event | 84274 |
| Product | PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702 |
| Product code | NBW |
| Recalling firm | Polymer Technology Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2020 |
| 510(k) numbers | K140068 |
| 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